Programming of cochlear implant accessories

ABSTRACT

Pairing systems for pairing external devices to a cochlear implant system can comprise an external housing and an external pairing system. The external housing may comprise a first surface and one or more compartments, each configured to house an external device capable of wirelessly interfacing with an implantable cochlear implant system. The external pairing device may comprise a second surface and one or more corresponding near field communication devices. The near field communication devices may be arranged such that the first surface of the external housing can be aligned with the second surface of the external pairing device in such a way that each of the near field communication devices aligns with a corresponding compartment of the external housing. The external pairing device can provide communication between a programming device and external devices contained within compartments of the external housing via one or more corresponding near field communication devices.

BACKGROUND

Cochlear implant systems are systems which may be at least partiallyimplanted surgically into and around the cochlea, the hearing organ ofthe ear, to provide improved hearing to a patient. Cochlear implantsystems may also be in communication with various devices internal tothe wearer as well as one or more external devices.

External devices may comprise a variety of components that can be usedto interact with the cochlear implant system or in tandem with thecochlear implant system to provide a better hearing experience for thepatient. However in some cases, external devices may need to be pairedwith the cochlear implant system prior to them communicating with thecochlear implant system. Manually pairing the various external deviceswith a wearer's implant system may prove to be costly both monetarily aswell as in time. For example, an audiologist may need to electricallycharge and manually pair various devices with a wearer's cochlearimplant system one-by-one. Charging each device enough to turn on andpair each device to the wearer's cochlear implant system can take anundesirably long time, and additional device to be paired can compoundthe delay. Furthermore, manually pairing each external device leavesroom for human error, such as forgetting to charge one or more externaldevices or forgetting to pair one or more external devices beforesending such a device home with the wearer. This may subsequentlyrequire a second appointment to fix any errors or pair missed devices.

SUMMARY

Some aspects of the disclosure are generally directed toward a pairingsystem for pairing one or more external devices to a cochlear implantsystem. In some examples, the pairing system may comprise an externalhousing, such as a box, a briefcase, or the like. The external housingmay have a first surface as well as a plurality of compartments arrangedin a first configuration such that each of the plurality of compartmentshas a unique position within the external housing relative to the firstsurface. Each of the plurality of compartments may be additionallyconfigured to house an external device capable of wirelessly interfacingwith a cochlear implant system, such as a fully implantable cochlearimplant system. In some embodiments, each of the plurality ofcompartments may be shaped as to receive a unique corresponding externaldevice however alternative shapes may be used.

Additionally or alternatively, the pairing device may include anexternal pairing device, such as a mat, a tabletop, or the like. Theexternal pairing device may comprise a second surface as well as aplurality of near field communication devices. In some embodiments, theplurality of near field communication devices may be arranged in aconfiguration corresponding to the first configuration and/or arrangedin the first configuration relative to the second surface such that thefirst surface of the external housing can be aligned with the secondsurface of the external pairing device in such a way that each of theplurality of near field communication devices aligns with acorresponding one of the plurality of compartments of the externalhousing. In some embodiments, the plurality of near field communicationdevices may be located beneath the second surface. The external pairingdevice may be configured to provide communication between a programmingdevice and one or more external devices, each contained with a differentcompartment of the external housing, via one or more corresponding nearfield communication devices of the external pairing device.

In some embodiments, the external pairing device may be configured toelectrically charge one or more external devices, each contained in acorresponding compartment of the external housing, via a correspondingone or more near field communication device of the external pairingdevice when the external housing is positioned proximate the externalpairing device and each of the plurality of near field communicationdevices aligns with a corresponding one of the plurality of compartmentsof the external housing. Additionally or alternatively, each near fieldcommunication device comprises a coil configured to facilitatecommunication with and charging of an external device within acorresponding compartment and having a corresponding coil.

In some embodiments, systems may comprise a cochlear implant system, aprogramming device, and one or more external devices. The cochlearimplant system may comprise a cochlear electrode, a stimulator, a signalprocessor, and an implantable battery and/or communication module. Insome embodiments, the programming device is configured to communicatewith each of the one or more external devices via corresponding nearfield communication devices of the external pairing device and provideinformation to each of the one or more external devices to enablecommunication between each external device and the cochlear implantsystem.

Additionally or alternatively, the programming device may be configuredto provide information to each of the one or more external devices toenable communication between each external device and the implantablebattery and/or communication module of the cochlear implant system.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic illustration of a fully implantable cochlearimplant system.

FIG. 2 shows an embodiment of a fully implantable cochlear implant.

FIG. 3 illustrates an embodiment of an exemplary middle ear sensor foruse in conjunction with anatomical features of a patient

FIG. 4 is a schematic diagram illustrating an exemplary implantablesystem including an acoustic stimulator.

FIG. 5A is a high level electrical schematic showing communicationbetween the implantable battery and/or communication module and thesignal processor.

FIG. 5B illustrates an exemplary schematic diagram illustrating acochlear electrode having a plurality of contact electrodes and fixedlyor detachably connected to an electrical stimulator.

FIG. 6A shows a high level schematic diagram illustrating an exemplarycommunication configuration between an implantable battery and/orcommunication module, a signal processor, and a stimulator in anexemplary cochlear implant system.

FIG. 6B is a schematic diagram illustrating exemplary electricalcommunication between an implantable battery and/or communication moduleand a signal processor in a cochlear implant system according to someembodiments.

FIG. 7A is an alternative high-level schematic diagram illustrating anexemplary communication configuration between an implantable batteryand/or communication module, a signal processor, and a stimulator.

FIG. 7B is an alternative schematic diagram illustrating exemplaryelectrical communication between an implantable battery and/orcommunication module and a signal processor in a cochlear implant systemsimilar to that shown in FIG. 7A.

FIG. 7C is another alternative schematic diagram illustrating exemplaryelectrical communication between an implantable battery and/orcommunication module and a signal processor in a cochlear implant systemsimilar to that shown in FIG. 7A.

FIG. 7D is high-level schematic diagram illustrating exemplaryelectrical communication between an implantable battery and/orcommunication module and a signal processor in a cochlear implant systemsimilar to that shown in FIG. 7A.

FIG. 8 is a process flow diagram illustrating an exemplary process forestablishing a preferred transfer function for a patient.

FIG. 9 is a schematic diagram illustrating possible communicationbetween a variety of system components according to some embodiments ofa fully implantable system.

FIG. 10 is an exemplary illustration of an external housing and anexternal pairing device for pairing one or more external devices with animplantable cochlear implant system.

FIG. 11 is an exemplary illustration of an external device establishinga connection with an implantable cochlear implant system and aprogramming device.

FIG. 12 provides an exemplary method of establishing a connectionbetween an external device and an implantable cochlear implant system.

FIG. 13 shows a process flow diagram showing an exemplary method forpairing another device with an implanted system using a paired charger.

FIG. 14 is a chart showing the various parameters that are adjustable byeach of a variety of external devices.

DETAILED DESCRIPTION

FIG. 1 shows a schematic illustration of a fully implantable cochlearimplant system. The system of FIG. 1 includes a middle ear sensor 110 incommunication with a signal processor 120. The middle ear sensor 110 canbe configured to detect incoming sound waves, for example, using the earstructure of a patient. The signal processor 120 can be configured toreceive a signal from the middle ear sensor 110 and produce an outputsignal based thereon. For example, the signal processor 120 can beprogrammed with instructions to output a certain signal based on areceived signal. In some embodiments, the output of the signal processor120 can be calculated using an equation based on received input signals.Alternatively, in some embodiments, the output of the signal processor120 can be based on a lookup table or other programmed (e.g., in memory)correspondence between the input signal from the middle ear sensor 110and the output signal. While not necessarily based explicitly on afunction, the relationship between the input to the signal processor 120(e.g., from the middle ear sensor 110) and the output of the signalprocessor 120 is referred to as the transfer function of the signalprocessor 120.

The system of FIG. 1 further includes a cochlear electrode 116 implantedinto the cochlear tissues of a patient. The cochlear electrode 116 is inelectrical communication with an electrical stimulator 130, which can beconfigured to provide electrical signals to the cochlear electrode 116in response to input signals received by the electrical stimulator 130.In some examples, the cochlear electrode 116 is fixedly attached to theelectrical stimulator 130. In other examples, the cochlear electrode 116is removably attached to the electrical stimulator 130. As shown, theelectrical stimulator 130 is in communication with the signal processor120. In some embodiments, the electrical stimulator 130 provideselectrical signals to the cochlear electrode 116 based on output signalsfrom the signal processor 120.

In various embodiments, the cochlear electrode 116 can include anynumber of contact electrodes in electrical contact with different partsof the cochlear tissue. In such embodiments, the electrical stimulator130 can be configured to provide electrical signals to any number ofsuch contact electrodes to stimulate the cochlear tissue. For example,in some embodiments, the electrical stimulator 130 is configured toactivate different contact electrodes or combinations of contactelectrodes of the cochlear electrode 116 in response to different inputsignals received from the signal processor 120. This can help thepatient differentiate between different input signals.

During exemplary operation, the middle ear sensor 110 detects audiosignals, for example, using features of the patient's ear anatomy asdescribed elsewhere herein and in U.S. Patent Publication No.2013/0018216, which is hereby incorporated by reference in its entirety.The signal processor 120 can receive such signals from the middle earsensor 110 and produce an output to the electrical stimulator 130 basedon the transfer function of the signal processor 120. The electricalstimulator 130 can then stimulate one or more contact electrodes of thecochlear electrode 116 based on the received signals from the signalprocessor 120.

Referring to FIG. 2 , an embodiment of a fully implantable cochlearimplant is shown. The device in this embodiment includes a processor 220(e.g., signal processor), a sensor 210, a first lead 270 connecting thesensor 210 to the processor 220, and a combination lead 280 attached tothe processor 220, wherein combination lead 280 contains both a groundelectrode 217 and a cochlear electrode 216. The illustrated processor220 includes a housing 202, a coil 208, first female receptacle 271 andsecond female receptacle 281 for insertion of the leads 270 and 280,respectively.

In some embodiments, coil 208 can receive power and/or data from anexternal device, for instance, including a transmission coil (notshown). Some such examples are described in U.S. Patent Publication No.2013/0018216, which is incorporated by reference. In other examples,processor 220 is configured to receive power and/or data from othersources, such as an implantable battery and/or communication module asshown in FIG. 1 . Such battery and/or communication module can beimplanted, for example, into the pectoral region of the patient in orderto provide adequate room for larger equipment (e.g., a relatively largebattery) for prolonged operation (e.g., longer battery life).Additionally, in the event a battery needs eventual replacement, areplacement procedure in the patient's pectoral region can be performedseveral times without certain vascularization issues that can arise nearthe location of the cochlear implant. For example, in some cases,repeated procedures (e.g., battery replacement) near the cochlearimplant can result in a decreased ability for the skin in the region toheal after a procedure. Placing a replaceable component such as abattery in the pectoral region can facilitate replacement procedureswith reduced risk for such issues.

FIG. 3 illustrates embodiments of an exemplary middle ear sensor for usein conjunction with anatomical features of a patient. Referring to FIG.3 , an embodiment of the sensor 310 of a fully implantable cochlearimplant is shown. Also shown are portions of the subject's anatomy,which includes, if the subject is anatomically normal, at least themalleus 322, incus 324, and stapes 326 of the middle ear 328, and thecochlea 348, oval window 346, and round window 344 of the inner ear 342.Here, the sensor 310 is touching the incus 324. Further, although notshown in a drawing, the sensor 310 may be in operative contact with thetympanic membrane or the stapes, or any combination of the tympanicmembrane, malleus 322, incus 324, or stapes 326.

FIG. 3 illustrates an exemplary middle ear sensor for use with systemsdescribed herein. However, other middle ear sensors can be used, such assensors using microphones or other sensors capable of receiving an inputcorresponding to detected sound and outputting a corresponding signal tothe signal processor. Additionally or alternatively, systems can includeother sensors configured to output a signal representative of soundreceived at or near a user's ear, such as a microphone or other acousticpickup located in the user's outer ear or implanted under the user'sskin. Such devices may function as an input source, for example, to thesignal processor such that the signal processor receives an input signalfrom the input source and generates and output one or more stimulationsignals according to the received input signal and the signal processortransfer function.

Referring back to FIG. 1 , the signal processor 120 is shown as being incommunication with the middle ear sensor 110, the electrical stimulator130, and the implantable battery and/or communication module 140. Asdescribed elsewhere herein, the signal processor 120 can receive inputsignals from the middle ear sensor 110 and/or other input source(s) andoutput signals to the electrical stimulator 130 for stimulating thecochlear electrode 116. The signal processor 120 can receive data (e.g.,processing data establishing or updating the transfer function of thesignal processor 120) and/or power from the implantable battery and/orcommunication module 140.

In some embodiments, the implantable battery and/or communication module140 can communicate with external devices, such as a programmer 100and/or a battery charger 102. The battery charger 102 can wirelesslycharge the battery in the implantable battery and/or communicationmodule 140 when brought into proximity with the implantable batteryand/or communication module 140 in the pectoral region of the patient.Such charging can be accomplished, for example, using inductivecharging. The programmer 100 can be configured to wirelessly communicatewith the implantable battery and/or communication module 140 via anyappropriate wireless communication technology, such as Bluetooth, Wi-Fi,and the like. In some examples, the programmer 100 can be used to updatethe system firmware and/or software. In an exemplary operation, theprogrammer 100 can be used to communicate an updated signal processor120 transfer function to the implantable battery and/or communicationmodule 140. In various embodiments, the programmer 100 and charger 102can be separate devices or can be integrated into a single device.

In the illustrated example of FIG. 1 , the signal processor 120 isconnected to the middle ear sensor 110 via lead 170. In someembodiments, lead 170 can provide communication between the signalprocessor 120 and the middle ear sensor 110. In some embodiments, lead170 can include a plurality of isolated conductors providing a pluralityof communication channels between the middle ear sensor 110 and thesignal processor 120. The lead 170 can include a coating such as anelectrically insulating sheath to minimize any conduction of electricalsignals to the body of the patient. In various embodiments, one or morecommunication leads can be detachable such that communication betweentwo components can be disconnected in order to electrically and/ormechanically separate such components. For instance, in someembodiments, lead 170 includes a detachable connector 171. Detachableconnector 171 can facilitate decoupling of the signal processor 120 andmiddle ear sensor 110. For example, with reference to FIG. 1 , in someembodiments, lead 170 can include a first lead extending from the middleear sensor 110 having one of a male (e.g., 672) or a female (e.g., 673)connector and a second lead extending from the signal processor 120having the other of the male or female connector. The first and secondleads can be connected at detachable connector 171 in order tofacilitate communication between the middle ear sensor 110 and thesignal processor 120.

In other examples, a part of the detachable connector 171 can beintegrated into one of the middle ear sensor 110 and the signalprocessor 120. For example, in an exemplary embodiment, the signalprocessor 120 can include a female connector integrated into a housingof the signal processor 120. Lead 170 can extend fully from the middleear sensor 110 and terminate at a corresponding male connector forinserting into the female connector of the signal processor 120. Instill further embodiments, a lead (e.g., 170) can include connectors oneach end configured to detachably connect with connectors integratedinto each of the components in communication. For example, lead 170 caninclude two male connectors, two female connectors, or one male and onefemale connector for detachably connecting with corresponding connectorsintegral to the middle ear sensor 110 and the signal processor 120.Thus, lead 170 may include two or more detachable connectors.

Similar communication configurations can be established for detachableconnector 181 of lead 180 facilitating communication between the signalprocessor 120 and the stimulator 130 and for detachable connector 191 oflead 190 facilitating communication between the signal processor 120 andthe implantable battery and/or communication module 140. Leads (170,180, 190) can include pairs of leads having corresponding connectorsextending from each piece of communicating equipment, or connectors canbe built in to any one or more communicating components.

In such configurations, each of the electrical stimulator 130, signalprocessor 120, middle ear sensor 110, and battery and/or communicationmodule can each be enclosed in a housing, such as a hermetically sealedhousing comprising biocompatible materials. Such components can includefeedthroughs providing communication to internal components enclosed inthe housing. Feedthroughs can provide electrical communication to thecomponent via leads extending from the housing and/or connectorsintegrated into the components.

In a module configuration such as that shown in FIG. 1 , variouscomponents can be accessed (e.g., for upgrades, repair, replacement,etc.) individually from other components. For example, as signalprocessor 120 technology improves (e.g., improvements in size,processing speed, power consumption, etc.), the signal processor 120implanted as part of the system can be removed and replacedindependently of other components. In an exemplary procedure, animplanted signal processor 120 can be disconnected from the electricalstimulator 130 by disconnecting detachable connector 181, from themiddle ear sensor 110 by disconnecting detachable connector 171, andfrom the implantable battery and/or communication module 140 bydisconnecting detachable connector 191. Thus, the signal processor 120can be removed from the patient while other components such as theelectrical stimulator 130, cochlear electrode 116, middle ear sensor110, and battery and/or communication module can remain in place in thepatient.

After the old signal processor is removed, a new signal processor can beconnected to the electrical stimulator 130, middle ear sensor 110, andimplantable battery and/or communication module 140 via detachableconnectors 181, 171, and 191, respectively. Thus, the signal processor(e.g., 120) can be replaced, repaired, upgraded, or any combinationthereof, without affecting the other system components. This can reduce,among other things, the risk, complexity, duration, and recovery time ofsuch a procedure. In particular, the cochlear electrode 116 can be leftin place in the patient's cochlea while other system components can beadjusted, reducing trauma to the patient's cochlear tissue.

Such modularity of system components can be particularly advantageouswhen replacing a signal processor 120, such as described above.Processor technology continues to improve and will likely continue tomarkedly improve in the future, making the signal processor 120 a likelycandidate for significant upgrades and/or replacement during thepatient's lifetime. Additionally, in embodiments such as the embodimentshown in FIG. 1 , the signal processor 120 communicates with many systemcomponents. For example, as shown, the signal processor 120 is incommunication with each of the electrical stimulator 130, the middle earsensor 110, and the implantable battery and/or communication module 140.Detachably connecting such components with the signal processor 120(e.g., via detachable connectors 181, 171, and 191) enables replacementof the signal processor 120 without disturbing any other components.Thus, in the event of an available signal processor 120 upgrade and/or afailure of the signal processor 120, the signal processor 120 can bedisconnected from other system components and removed.

While many advantages exist for a replaceable signal processor 120, themodularity of other system components can be similarly advantageous, forexample, for upgrading any system component. Similarly, if a systemcomponent (e.g., the middle ear sensor 110) should fail, the componentcan be disconnected from the rest of the system (e.g., via detachableconnector 171) and replaced without disturbing the remaining systemcomponents. In another example, even a rechargeable battery included inthe implantable battery and/or communication module 140 may eventuallywear out and need replacement. The implantable battery and/orcommunication module 140 can be replaced or accessed (e.g., forreplacing the battery) without disturbing other system components.Further, as discussed elsewhere herein, when the implantable batteryand/or communication module 140 is implanted in the pectoral region ofthe patient, such as in the illustrated example, such a procedure canleave the patient's head untouched, eliminating unnecessarily frequentaccess beneath the skin.

While various components are described herein as being detachable, invarious embodiments, one or more components configured to communicatewith one another can be integrated into a single housing. For example,in some embodiments, signal processor 120 can be integrally formed withthe stimulator 130 and cochlear electrode 116. For example, in anexemplary embodiment, processing and stimulation circuitry of a signalprocessor 120 and stimulator 130 can be integrally formed as a singleunit in a housing coupled to a cochlear electrode. Cochlear electrodeand the signal processor/stimulator can be implanted during an initialprocedure and operate as a single unit.

In some embodiments, while the integral signalprocessor/stimulator/cochlear electrode component does not get removedfrom a patient due to potential damage to the cochlear tissue into whichthe cochlear electrode is implanted, system upgrades are still possible.For example, in some embodiments, a module signal processor may beimplanted alongside the integral signal processor/stimulator componentand communicate therewith. In some such examples, the integral signalprocessor may include a built-in bypass to allow a later-implantedsignal processor to interface directly with the stimulator. Additionallyor alternatively, the modular signal processor can communicate with theintegral signal processor, which may be programmed with a unity transferfunction. Thus, in some such embodiments, signals from the modularsignal processor may be essentially passed through the integral signalprocessor unchanged so that the modular signal processor effectivelycontrols action of the integral stimulator. Thus, in variousembodiments, hardware and/or software solutions exist for upgrading anintegrally attached signal processor that may be difficult or dangerousto remove.

While often described herein as using an electrical stimulator tostimulate the patient's cochlear tissue via a cochlear electrode, insome examples, the system can additionally or alternatively include anacoustic stimulator. An acoustic stimulator can include, for example, atransducer (e.g., a piezoelectric transducer) configured to providemechanical stimulation to the patient's ear structure. In an exemplaryembodiment, the acoustic stimulator can be configured to stimulate oneor more portions of the patient's ossicular chain via amplifiedvibrations. Acoustic stimulators can include any appropriate acousticstimulators, such as those found in the ESTEEM™ implant (Envoy MedicalCorp., St. Paul, Minn.) or as described in U.S. Pat. Nos. 4,729,366,4,850,962, and 7,524,278, and U.S. Patent Publication No. 20100042183,each of which is incorporated herein by reference in its entirety.

FIG. 4 is a schematic diagram illustrating an exemplary implantablesystem including an acoustic stimulator. The acoustic stimulator can beimplanted proximate the patient's ossicular chain and can be incommunication with a signal processor via lead 194 and detachableconnector 195. The signal processor can behave as described elsewhereherein and can be configured to cause acoustic stimulation of theossicular chain via the acoustic stimulator in in response to inputsignals from the middle ear sensor according to a transfer function ofthe signal processor.

The acoustic stimulator of FIG. 4 can be used similarly to theelectrical stimulator as described elsewhere herein. For instance, anacoustic stimulator can be mechanically coupled to a patient's ossicularchain upon implanting the system and coupled to the signal processor vialead 194 and detachable connector 195. Similarly to systems describedelsewhere herein with respect to the electrical stimulator, if thesignal processor requires replacement or repair, the signal processorcan be disconnected from the acoustic stimulator (via detachableconnector 195) so that the signal processor can be removed withoutdisturbing the acoustic stimulator.

Some systems can include a hybrid system comprising both an electricalstimulator and an acoustic stimulator in communication with the signalprocessor. In some such examples, the signal processor can be configuredto stimulate electrically and/or acoustically according to the transferfunction of the signal processor. In some examples, the type ofstimulation used can depend on the input signal received by the signalprocessor. For instance, in an exemplary embodiment, the frequencycontent of the input signal to the signal processor can dictate the typeof stimulation. In some cases, frequencies below a threshold frequencycould be represented using one of electrical and acoustic stimulationwhile frequencies above the threshold frequency could be representedusing the other of electrical and acoustic stimulation. Such a thresholdfrequency could be adjustable based on the hearing profile of thepatient. Using a limited range of frequencies can reduce the number offrequency domains, and thus the number of contact electrodes, on thecochlear electrode. In other examples, rather than a single thresholdfrequency defining which frequencies are stimulated electrically andacoustically, various frequencies can be stimulated both electricallyand acoustically. In some such examples, the relative amount ofelectrical and acoustic stimulation can be frequency-dependent. Asdescribed elsewhere herein, the signal processor transfer function canbe updated to meet the needs of the patient, including the electricaland acoustic stimulation profiles.

With further reference to FIGS. 1 and 4 , in some examples, a system caninclude a shut-off controller 104, which can be configured to wirelesslystop an electrical stimulator 130 from stimulating the patient'scochlear tissue and/or an acoustic stimulator 150 from stimulating thepatient's ossicular chain. For example, if the system is malfunctioningor an uncomfortably loud input sound causes an undesirable level ofstimulation, the user may use the shut-off controller 104 to ceasestimulation from the stimulator 130. The shut-off controller 104 can beembodied in a variety of ways. For example, in some embodiments, theshut-off controller 104 can be integrated into other external devices,such as the programmer 100. In some such examples, the programmer 100includes a user interface by which a user can select an emergencyshut-off feature to cease stimulation. Additionally or alternatively,the shut-off controller 104 can be embodied as a separate component.This can be useful in situations in which the patient may not haveimmediate access to the programmer 100. For example, the shut-offcontroller 104 can be implemented as a wearable component that thepatient can wear at all or most times, such as a ring, bracelet,necklace, or the like.

The shut-off controller 104 can communicate with the system in order tostop stimulation in a variety of ways. In some examples, the shut-offcontroller 104 comprises a magnet that is detectable by a sensor (e.g.,a Hall-Effect sensor) implanted in the patient, such as in the processorand/or the implantable battery and/or communication module 140. In somesuch embodiments, when the magnet is brought sufficiently close to thesensor, the system can stop stimulation of the cochlear tissue orossicular chain.

After the shut-off controller 104 is used to disable stimulation,stimulation can be re-enabled in one or more of a variety of ways. Forexample, in some embodiments, stimulation is re-enabled after apredetermined amount of time after it had been disabled. In otherexamples, the shut-off controller 104 can be used to re-enablestimulation. In some such examples, the patient brings the shut-offcontroller 104 within a first distance of a sensor (e.g., a magneticsensor) to disable stimulation, and then removes the shut-off controller104. Subsequently, once the patient brings the shut-off controller 104within a second distance of the sensor, stimulation can be re-enabled.In various embodiments, the first distance can be less than the seconddistance, equal to the second distance, or greater than the seconddistance. In still further embodiments, another device such as aseparate turn-on controller (not shown) or the programmer 100 can beused to re-enable stimulation. Any combination of such re-enabling ofstimulation can be used, such as alternatively using either theprogrammer 100 or the shut-off controller 104 to enable stimulation orcombining a minimum “off” time before any other methods can be used tore-enable stimulation.

In some embodiments, rather than entirely disable stimulation, otheractions can be taken, such as reducing the magnitude of stimulation. Forexample, in some embodiments, the shut-off sensor can be used to reducethe signal output by a predetermined amount (e.g., absolute amount,percentage, etc.). In other examples, the shut-off sensor can affect thetransfer function of the signal processor to reduce the magnitude ofstimulation in a customized way, such as according to frequency or otherparameter of an input signal (e.g., from the middle ear sensor).

With reference back to FIG. 1 , as described elsewhere herein, theimplantable battery and/or communication module can be used to providepower and/or data (e.g., processing instructions) to other systemcomponents via lead 190. Different challenges exist for communicatingelectrical signals through a patient's body. For example, safetystandards can limit the amount of current that can safely flow through apatient's body (particularly DC current). Additionally, the patient'sbody can act as an undesired signal path from component to component(e.g., via contact with the housing or “can” of each component). Varioussystems and methods can be employed to improve the communication abilitybetween system components.

FIG. 5A is a high level electrical schematic showing communicationbetween the implantable battery and/or communication module and thesignal processor. In the illustrated embodiment, the implantable batteryand/or communication module includes circuitry in communication withcircuitry in the signal processor. Communication between the circuitryin the implantable battery and/or communication module and the signalprocessor can be facilitated by a lead (190), represented by the leadtransfer function. The lead transfer function can include, for example,parasitic resistances and capacitances between the leads connecting theimplantable battery and/or communication module and the signal processorand the patient's body and/or between two or more conductors that makeup the lead (e.g., 191). Signals communicated from the circuitry of theimplantable battery and/or communication module to the circuitry in thesignal processor can include electrical power provided to operate and/orstimulate system components (e.g., the middle ear sensor, signalprocessor, electrical and/or acoustic stimulator, and/or cochlearelectrode) and/or data (e.g., processing data regarding the transferfunction of the signal processor).

As discussed elsewhere herein, the body of the patient provides anelectrical path between system components, such as the “can” of theimplantable battery and/or communication module and the “can” of thesignal processor. This path is represented in FIG. 5A by the flow paththrough R_(Body). Thus, the patient's body can provide undesirablesignal paths which can negatively impact communication betweencomponents. To address this, in some embodiments, operating circuitry ineach component can be substantially isolated from the component “can”and thus the patient's body. For example, as shown, resistance R_(Can)is positioned between the circuitry and the “can” of both theimplantable battery and/or communication module and the signalprocessor.

While being shown as R_(Can) in each of the implantable battery and/orcommunication module and the signal processor, it will be appreciatedthat the actual value of the resistance between the circuitry andrespective “can” of different elements is not necessarily equal.Additionally, R_(Can) need not include purely a resistance, but caninclude other components, such as one or more capacitors, inductors, andthe like. That is, R_(Can) can represent an insulating circuit includingany variety of components that act to increase the impedance betweencircuitry within a component and the “can” of the component. Thus,R_(Can) can represent an impedance between the operating circuitry of acomponent and the respective “can” and the patient's tissue. Isolatingthe circuitry from the “can” and the patient's body acts to similarlyisolate the circuitry from the “can” of other components, allowing eachcomponent to operate with reference to a substantially isolatedcomponent ground. This can eliminate undesired communication andinterference between system components and/or between system componentsand the patient's body.

For example, as described elsewhere herein, in some examples, anelectrical stimulator can provide an electrical stimulus to one or morecontact electrodes on a cochlear electrode implanted in a patient'scochlear tissue. FIG. 5B illustrates an exemplary schematic diagramillustrating a cochlear electrode having a plurality of contactelectrodes and fixedly or detachably connected to an electricalstimulator. As shown, the cochlear electrode 500 has four contactelectrodes 502, 504, 506, and 508, though it will be appreciated thatany number of contact electrodes is possible. As described elsewhereherein, the electrical stimulator can provide electrical signals to oneor more such contact electrodes in response to an output from the signalprocessor according to the transfer function thereof and a receivedinput signal.

Because each contact electrode 502-508 is in contact with the patient'scochlear tissue, each is separated from the “can” of the electricalstimulator (as well as the “cans” of other system components) via theimpedance of the patient's tissue, shown as R_(Body). Thus, if thecircuitry within various system components did not have sufficientlyhigh impedance (e.g., R_(Can)) to the component “can”, electricalsignals may stimulate undesired regions of the patient's cochleartissue. For instance, stimulation intended for a particular contactelectrode (e.g., 502) may lead to undesired stimulation of other contactelectrodes (e.g., 504, 506, 508), reducing the overall efficacy of thesystem. Minimizing the conductive paths between system components (e.g.,to the contact electrodes of a cochlear electrode) due to the patient'sbody, such as by incorporating impedances between component circuitryand the corresponding “can” via R_(Can), can therefore improve theability to apply an electrical stimulus to only a desired portion of thepatient's body.

It will be appreciated that the term R_(Body) is used herein togenerally represent the resistance and/or impedance of the patient'stissue between various components and does not refer to a specificvalue. Moreover, each depiction or R_(Body) in the figures does notnecessarily represent the same value of resistance and/or impedance asthe others.

FIG. 6A shows a high level schematic diagram illustrating an exemplarycommunication configuration between an implantable battery and/orcommunication module, a signal processor, and a stimulator. In theexample of FIG. 6A, the implantable battery and/or communication module610 is in two-way communication with the signal processor 620. Forinstance, the implantable battery and/or communication module 610 cancommunicate power and/or data signals 650 to the signal processor 620.In some examples, the power and data signals 650 can be included in asingle signal generated in the implantable battery and/or communicationmodule 610 and transmitted to the signal processor 620. Such signals caninclude, for example, a digital signal transmitted with a particularclock rate, which in some embodiments, can be adjustable, for example,via the implantable battery and/or communication module 610.

In some embodiments, the signal processor 620 can communicateinformation to the implantable battery and/or communication module 610(e.g., 651), for example, feedback information and/or requests for morepower, etc. The implantable battery and/or communication module 610 can,in response, adjust its output to the signal processor 620 (e.g., anamplitude, duty cycle, clock rate, etc.) in order to accommodate for thereceived feedback (e.g., to provide more power, etc.). Thus, in somesuch examples, the implantable battery and/or communication module 610can communicate power and data (e.g., 650) to the signal processor 620,and the signal processor 620 can communicate various data back to theimplantable battery and/or communication module 610 (e.g., 651).

In some embodiments, similar communication can be implemented betweenthe signal processor 620 and the stimulator 630, wherein the signalprocessor 620 provides power and data to the stimulator 630 (e.g., 660)and receives data in return from the stimulator 630 (e.g., 661). Forexample, the signal processor 620 can be configured to output signals(e.g., power and/or data) to the stimulator 630 (e.g., based on receivedinputs from a middle ear sensor or other device) via a similarcommunication protocol as implemented between the implantable batteryand/or communication module 610 and the signal processor 620. Similarly,in some embodiments, the stimulator can be configured to providefeedback signals to the signal processor, for example, representative ofan executed stimulation process. Additionally or alternatively, thestimulator may provide diagnostic information, such as electrodeimpedance and neural response telemetry or other biomarker signals.

FIG. 6B is a schematic diagram illustrating exemplary electricalcommunication between an implantable battery and/or communication moduleand a signal processor in a cochlear implant system according to someembodiments. In the illustrated embodiment, the implantable batteryand/or communication module 610 includes a signal generator 612configured to output a signal through a lead (e.g., 190) to the signalprocessor 620. As described with respect to FIG. 6A, in some examples,the signal generator 612 is configured to generate both data and powersignals (e.g., 650) for communication to the signal processor 620. Insome embodiments, the signal generator 612 generates a digital signalfor communication to the signal processor 620. The digital signal fromthe signal generator 612 can be communicated to the signal processor 620at a particular clock rate. In some examples, the signals are generatedat approximately 30 kHz. In various examples, data and power frequenciescan range from approximately 100 Hz to approximately 10 MHz, and in someexamples, may be adjustable, for example, by a user.

In the illustrated embodiment, the implantable battery and/orcommunication module 610 includes a controller in communication with thesignal generator 612. In some examples, the controller is capable ofadjusting communication parameters such as the clock rate of the signalgenerator 612. In an exemplary embodiment, the controller and/or thesignal generator 612 can communicate with, for example, a patient'sexternal programmer (e.g., as shown in FIG. 1 ). The controller and/orsignal generator 612 can be configured to communicate data to the signalprocessor 620 (e.g., 651), such as updated firmware, signal processor620 transfer functions, or the like.

As shown, the signal generator 612 outputs the generated signal to anamplifier 690 and an inverting amplifier 692. In some examples, bothamplifiers are unity gain amplifiers. In some examples comprisingdigital signals, the inverting amplifier 692 can comprise a digital NOTgate. The output from the amplifier 690 and the inverting amplifier 692are generally opposite one another and are directed to the signalprocessor 620. In some embodiments, the opposite nature of the signalsoutput to the signal processor 620 from amplifiers 690 and 692 resultsin a charge-neutral communication between the implantable battery and/orcommunication module 610 and the signal processor 620, such that no netcharge flows through the wearer.

In the illustrated example of FIG. 6B, the receiving circuitry in thesignal processor 620 comprises a rectifier circuit 622 that receivessignals (e.g., 650) from the amplifier 690 and the inverting amplifier692. Since the output of one of the amplifiers 690 and 692 will be high,the rectifier circuit 622 can be configured to receive the oppositesignals from the amplifiers 690 and 692 and generate therefrom asubstantially DC power output 623. In various embodiments, the DC power623 can be used to power a variety of components, such as the signalprocessor 620 itself, the middle ear sensor, the electrical and/oracoustic stimulator, or the like. The rectifier circuit 622 can includeany known appropriate circuitry components for rectifying one or moreinput signals, such as a diode rectification circuit or a transistorcircuit, for example.

As described elsewhere herein, the implantable battery and/orcommunication module 610 can communicate data to the signal processor620. In some embodiments, the controller and/or the signal generator 612is configured to encode the data for transmission via the outputamplifiers 690 and 692. The signal processor 620 can include a signalextraction module 624 configured to extract the data signal 625 from thesignal(s) (e.g., 650) communicated to the signal processor 620 toproduce a signal for use by the signal processor 620. In some examples,the signal extraction module 624 is capable of decoding the signal thatwas encoded by the implantable battery and/or communication module 610.Additionally or alternatively, the signal extraction module 624 canextract a signal 625 resulting from the lead transfer function. Invarious examples, the extracted signal 625 can include, for example, anupdated transfer function for the signal processor 620, a desiredstimulation command, or other signals that affect operation of thesignal processor 620.

In the illustrated example, the signal processor 620 includes acontroller 626 that is capable of monitoring the DC power 623 and thesignal 625 received from the implantable battery and/or communicationmodule 610. The controller 626 can be configured to analyze the receivedDC power 623 and the signal 625 and determine whether or not the powerand/or signal is sufficient. For example, the controller 626 maydetermine that the signal processor 620 is receiving insufficient DCpower for stimulating a cochlear electrode according to the signalprocessor 620 transfer function, or that data from the implantablebattery and/or communication module 610 is not communicated at a desiredrate. Thus, in some examples, the controller 626 of the signal processor620 can communicate with the controller 614 of the implantable batteryand/or communication module 610 and provide feedback regarding thereceived communication. Based on the received feedback from thecontroller 626 of the signal processor 620, the controller 614 of theimplantable battery and/or communication module 610 can adjust variousproperties of the signal output by the implantable battery and/orcommunication module 610. For example, the controller of the implantablebattery and/or communication module 610 can adjust the clock rate of thecommunication from the signal generator 612 to the signal processor 620.

In some systems, the transmission efficiency between the implantablebattery and/or communication module 610 and the signal processor 620 isdependent on the clock rate of transmission. Accordingly, in someexamples, the implantable battery and/or communication module 610 beginsby transmitting at an optimized clock rate until a change in clock rateis requested via the signal processor 620, for example, to enhance datatransmission (e.g., rate, resolution, etc.). In other instances, if morepower is required (e.g., the controller of the signal processor 620determines the DC power is insufficient), the clock rate can be adjustedto improve transmission efficiency, and thus the magnitude of the signalreceived at the signal processor 620. It will be appreciated that inaddition or alternatively to adjusting a clock rate, adjusting an amountof power transmitted to the signal processor 620 can include adjustingthe magnitude of the signal output from the signal generator 612. Insome embodiments, for example, with respect to FIGS. 6A-B, power anddata can be communicated, for example, from implantable battery and/orcommunication module 610 to the signal processor 620 at a rate ofapproximately 30 kHz, and can be adjusted from there as necessary and/oras requested, for example, by the signal processor 620.

FIG. 7A is an alternative high-level schematic diagram illustrating anexemplary communication configuration between an implantable batteryand/or communication module, a signal processor, and a stimulator. Inthe example of FIG. 7A, the implantable battery and/or communicationmodule 710 provides signals (e.g., 750) to the signal processor 720 viaa first communication link and is further in two-way communication forproviding additional signals (e.g., 751) with the signal processor 720.In the example of FIG. 7A, the implantable battery and/or communicationmodule 710 can provide power signals (e.g., 750) to the signal processor720 via a communication link and otherwise be in two-way datacommunication (751) with the signal processor 720 via a secondcommunication link. In some such examples, the power (750) and data(751) signals can each include digital signals. However, in someembodiments, the power and data signals are transmitted at differentclock rates. In some examples, the clock rate of the data signals is atleast one order of magnitude greater than the clock rate of the powersignals. For example, in an exemplary embodiment, the power signal iscommunicated at a clock rate of approximately 30 kHz, while the datacommunication occurs at a clock rate of approximately 1 MHz. Similarlyto the embodiment described in FIG. 6A, in some examples, the clock ratecan be adjustable, for example, via the implantable battery and/orcommunication module 710.

As described with respect to FIG. 6A, in some embodiments, the signalprocessor 720 can communicate information to the implantable batteryand/or communication module 710, for example, feedback informationand/or requests for more power, etc. (e.g., data signals 751). Theimplantable battery and/or communication module 710 can, in response,adjust the power and/or data output to the signal processor 720 (e.g.,an amplitude, duty cycle, clock rate, etc.) in order to accommodate forthe received feedback (e.g., to provide more power, etc.).

In some embodiments, similar communication can be implemented betweenthe signal processor 720 and the stimulator 730, wherein the signalprocessor 720 provides power and data to the stimulator 730 and receivesdata in return from the stimulator 730. For example, the signalprocessor 720 can be configured to output signals power signals (e.g.,760) and data signals (e.g., 761) to the stimulator 730 (e.g., based onreceived inputs from a middle ear sensor or other device). Suchcommunication can be implemented via a similar communication protocol asimplemented between the implantable battery and/or communication module710 and the signal processor 720. In some examples, the power signalsprovided to the stimulator 730 (e.g., 760) are the same signals (e.g.,750) received by the signal processor 720 from the implantable batteryand/or communication module 710. Additionally, in some embodiments, thestimulator 730 can be configured to provide feedback signals to thesignal processor 720 (e.g., 761), for example, representative of anexecuted stimulation process.

FIG. 7B is an alternative schematic diagram illustrating exemplaryelectrical communication between an implantable battery and/orcommunication module 710 b and a signal processor 720 b in a cochlearimplant system similar to that shown in FIG. 7A. In the illustratedembodiment of FIG. 7B, the implantable battery and/or communicationmodule 710 b includes a power signal generator 711 and a separate signalgenerator 712. The power signal generator 711 and signal generator 712are each configured to output a signal through a lead (e.g., 190) to thesignal processor 720 b. In some embodiments, the power signal generator711 and the signal generator 712 each generates digital signal forcommunication to the signal processor 720 b. In some such embodiments,the digital signal (e.g., 750) from the power signal generator 711 canbe communicated to the signal processor 720 b at a power clock rate,while the digital signal (e.g., 751 b) from the signal generator 712 canbe communicated to the signal processor 720 b at a data clock rate thatis different from the power clock rate. For instance, in someconfigurations, power and data can be communicated most effectivelyand/or efficiently at different clock rates. In an exemplary embodiment,the power clock rate is approximately 30 kHz while the data clock rateis approximately 1 MHz. Utilizing different and separately communicatedpower and data signals having different clock rates can increase thetransfer efficiency of power and/or data from the implantable batteryand/or communication module 710 b to the signal processor 720 b.

In the illustrated embodiment, the implantable battery and/orcommunication module 710 b includes a controller 714 in communicationwith the power signal generator 711 and the signal generator 712. Insome examples, the controller 714 is capable of adjusting communicationparameters such as the clock rate or content of the signal generator 712and/or the power signal generator 711. In an exemplary embodiment, thecontroller 714 and/or the signal generator 712 or power signal generator711 can communicate with, for example, a patient's external programmer(e.g., as shown in FIG. 1 ). The controller 714 and/or signal generator712 can be configured to communicate data to the signal processor 720 b,such as updated firmware, signal processor 720 b transfer functions, orthe like. Additionally or alternatively, the controller 714 can beconfigured to transmit signals such as audio or other signals streamedor otherwise received from one or more external devices as describedelsewhere herein.

As shown, and similar to the example shown in FIG. 6B, the power signalgenerator 711 outputs the generated signal to an amplifier 790 and aninverting amplifier 792. In some examples, both amplifiers are unitygain amplifiers. In some examples comprising digital signals, theinverting amplifier 792 can comprise a digital NOT gate. The output fromthe amplifier 790 and the inverting amplifier 792 are generally oppositeone another and are directed to the signal processor 720 b. In theillustrated example, the receiving circuitry in the signal processor 720b comprises a rectifier circuit 722 that receives signals from theamplifier 790 and the inverting amplifier 792. Since the output of oneof the amplifiers 790 and 792 will be high, the rectifier circuit 722can be configured to receive the opposite signals from the amplifiers790 and 792 and generate therefrom a substantially DC power output 723.

In various embodiments, the DC power 723 can be used to power a varietyof components, such as the signal processor 720 b itself, the middle earsensor, the electrical and/or acoustic stimulator 730, or the like. Therectifier circuit 722 can include any known appropriate circuitrycomponents for rectifying one or more input signals, such as a dioderectification circuit or a transistor circuit, for example. In someembodiments, signals from the power signal generator 711 are generatedat a clock rate that is optimal for transmitting power through the lead(e.g., approximately 30 kHz). In the illustrated example of FIG. 7B, therectifier circuit 722 can be arranged in parallel with power lines thatare configured to communicate power signals to other components withinthe system, such as the stimulator 730, for example. For instance, insome embodiments, the same power signal (e.g., 750) generated from thepower signal generator 711 and output via amplifiers 790 and 792 can besimilarly applied to the stimulator 730. In some such examples, thestimulator 730 includes a rectifier circuit 722 similar to the signalprocessor 720 b for extracting DC power from the power signal and theinverted power signal provided by amplifiers 790 and 792, respectively.In alternative embodiments, the signal processor 720 b can similarlyprovide signals from a separate power signal generator 711 to providepower signals (e.g., at approximately 30 kHz) to the stimulator 730similar to how power is provided from the implantable battery and/orcommunication module 710 b to the signal processor 720 b in FIG. 7B.

In the example of FIG. 7B, the signal generator 712 outputs a datasignal (e.g., 751 b) to an amplifier 794 and an inverting amplifier 796.In some examples, both amplifiers are unity gain amplifiers. In someexamples comprising digital signals, the inverting amplifier 796 cancomprise a digital NOT gate. The output from the amplifier 794 and theinverting amplifier 796 are generally opposite one another and aredirected to the signal processor 720 b.

As described elsewhere herein, in some embodiments, the controller 714and/or the signal generator 712 is configured to encode data fortransmission via the output amplifiers 794 and 796. The signal processor720 b can include a signal extraction module 724 configured to extractthe data from the signal(s) 725 communicated to the signal processor 720b to produce a signal 725 for use by the signal processor 720 b. In someexamples, the signal extraction module 724 is capable of decoding thesignal that was encoded by the implantable battery and/or communicationmodule 710 b. Additionally or alternatively, the signal extractionmodule 724 can extract a resulting signal 725 resulting from the leadtransfer function. In various examples, the extracted signal caninclude, for example, an updated transfer function for the signalprocessor 720 b, a desired stimulation command, or other signals thataffect operation of the signal processor 720 b.

In the example of FIG. 7B, the signal extraction module 724 includes apair of tri-state buffers 786 and 788 in communication with signalsoutput from the signal generator 712. The tri-state buffers 786 and 788are shown as having “enable” (ENB) signals provided by controller 726 inorder to control operation of the tri-state buffers 786 and 788 forextracting the signal from the signal generator 712. Signals from thesignal generator 712 and buffered by tri-state buffers 786 and 788 arereceived by amplifier 784, which can be configured to produce a signal725 representative of the signal generated by the signal generator 712.

In some examples, communication of signals generated at the signalgenerator 712 can be communicated to the signal processor 720 b at aclock rate that is different from the clock rate of the signalsgenerated by the power signal generator 711. For instance, in someembodiments, power signals from the power signal generator 711 aretransmitted at approximately 30 kHz, which can be an efficient frequencyfor transmitting power. However, in some examples, the signals from thesignal generator 712 are transmitted at a higher frequency than thesignal from the power signal generator 711, for example, atapproximately 1 MHz. Such high frequency data transmission can be usefulfor faster data transfer than would be available at lower frequencies(e.g., the frequencies for transmitting the signal from the power signalgenerator 711). Thus, in some embodiments, power and data can becommunicated from the implantable battery and/or communication module710 b to the signal processor 720 b via different communication channelsat different frequencies.

Similar to the embodiment shown in FIG. 6B, in the illustrated exampleof FIG. 7B, the signal processor 720 b includes a controller 726 that isin communication with the implantable battery and/or communicationmodule 710 b. In some such embodiments, the controller 726 in the signalprocessor 720 b is capable of monitoring the DC power 723 and/or thesignal 725 received from the implantable battery and/or communicationmodule 710 b. The controller 726 can be configured to analyze thereceived DC power 723 and the signal 725 and determine whether or notthe power and/or signal is sufficient. For example, the controller 726may determine that the signal processor 720 b is receiving insufficientDC power for stimulating a cochlear electrode according to the signalprocessor 720 b transfer function, or that data from the implantablebattery and/or communication module 710 b is not communicated at adesired rate. Thus, in some examples, the controller 726 of the signalprocessor 720 b can communicate with the controller 714 of theimplantable battery and/or communication module 710 b and providefeedback regarding the received communication. Based on the receivedfeedback from the controller 726 of the signal processor 720 b, thecontroller 714 of the implantable battery and/or communication module710 b can adjust various properties of the signals output by the powersignal generator 711 and/or the signal generator 712.

In the illustrated example of FIG. 7B, bidirectional communicationsignals 751 b between the implantable battery and/or communicationmodule 710 b and signal processor 720 b comprises signals from theamplifiers 794 and 796 in one direction, and communication fromcontroller 726 to controller 714 in the other direction. It will beappreciated that a variety of communication protocols and techniques canbe used in establishing bidirectional communication signals 751 bbetween the implantable battery and/or communication module 710 b andsignal processor 720 b.

For example, in some embodiments, the implantable battery and/orcommunication module 710 b need not include amplifiers 794 and 796, andinstead transmits a signal and not its inverse to the signal processor720 b. In other examples, the signal processor includes amplifierssimilar to 794 and 796, and outputs a signal and its inverse back to theimplantable battery and/or communication module 710 b. Additionally oralternatively, in some embodiments, the signal generator 712 can beintegral with the controller 714 and/or the signal extraction module 724can be integral with controller 726, wherein controllers 714 and 726 canbe in bidirectional communication via signal generator 712 and/or thesignal extraction module 724. In general, the implantable battery and/orcommunication module 710 b and the signal processor 720 b can be inbidirectional communication for communicating data signals separate fromthe power signals provided by power signal generator 711.

As described, separate communication channels for power (e.g., 750) anddata (e.g., 751 b) can be used for providing both power and data fromthe implantable battery and/or communication module 710 b and the signalprocessor 720 b. This can allow for separate data and power clockingrates in order to improve the power transmission efficiency as well asthe data transmission efficiency and/or rate. Moreover, in someexamples, if the bidirectional communication (e.g., 751 b) between theimplantable battery and/or communication module 710 b and the signalprocessor 720 b fails (e.g., due to component failure, connectionfailure, etc.), data for communication from the implantable batteryand/or communication module 710 b can be encoded in the power signals(e.g., 750) from the power signal generator 711 and transmitted to thesignal processor 720 b. Thus, similar to the embodiment described withrespect to FIG. 6B, both power and data can be transmitted via the samesignal.

In some examples, the signal extraction module 724 can be configured toreceive data received from the power signal generator 711, for example,via an actuatable switch that can be actuated upon detected failure ofcommunication 751 b. In other examples, the signal extraction module 724and/or the controller 726 can generally monitor data from the powersignal generator 711 and identify when signals received from the powersignal generator 711 include data signals encoded into the receivedpower signal in order to determine when to consider the power signals toinclude data.

Accordingly, in some embodiments, the configuration of FIG. 7B can beimplemented to establish efficient, bidirectional communication betweenthe implantable battery and/or communication module 710 b and the signalprocessor 720 b. Failure in bidirectional communication 751 b can beidentified manually and/or automatically. Upon detection of failure inthe bidirectional communication 751 b, the controller 714 can encodedata into the power signal output from the power signal generator 711,and power and data can be combined into a single signal such asdescribed with respect to FIG. 6B.

FIG. 7C is another alternative schematic diagram illustrating exemplaryelectrical communication between an implantable battery and/orcommunication module 710 c and a signal processor 720 c in a cochlearimplant system similar to that shown in FIG. 7A. Similar to theembodiment of FIG. 7B, in the illustrated embodiment of FIG. 7C, theimplantable battery and/or communication module 710 c includes a powersignal generator 711 configured to output a signal through a lead (e.g.,190) to the signal processor 720 c. In some embodiments, the powersignal generator 711 generates a digital signal (e.g., 750) forcommunication to the signal processor 720 c, for example, at a powerclock rate. The power signal generator 711 and corresponding amplifiers790, 792, as well as rectifier circuit 722, can operate similar todescribed with respect to FIG. 7B in order to extract DC power 723 and,in some examples, output power signals to further system components,such as stimulator 730.

In the illustrated embodiment, the implantable battery and/orcommunication module 710 c includes a signal generator 713, which can becapable of providing data signals to the signal processor. In someembodiments, the signal generator 713 generates a digital signal forcommunication to the signal processor 720 c. In some such embodiments,the digital signal (e.g., 751 c) from the signal generator 713 can becommunicated to the signal processor 720 b at a data clock rate that isdifferent from the power clock rate. For instance, as describedelsewhere herein, in some configurations, power and data can becommunicated most effectively and/or efficiently at different clockrates. In an exemplary embodiment, the power clock rate is approximately30 kHz while the data clock rate is approximately 1 MHz. Utilizingdifferent and separately communicated power and data signals havingdifferent clock rates can increase the transfer efficiency of powerand/or data from the implantable battery and/or communication module 710c to the signal processor 720 c.

The embodiment of FIG. 7C includes a controller 715 in communicationwith the power signal generator 711 and the signal generator 713. Insome examples, the controller 715 is capable of adjusting communicationparameters such as the clock rate or content of the signal generator 713and/or the power signal generator 711. In an exemplary embodiment, thecontroller 715 and/or the signal generator 713 or power signal generator711 can communicate with, for example, a patient's external programmer(e.g., as shown in FIG. 1 ). The controller 715 and/or signal generator713 can be configured to communicate data to the signal processor 720 c,such as updated firmware, signal processor 720 c transfer functions, orthe like.

Similar to the example in FIG. 7B, in the example of FIG. 7C, the signalgenerator 713 outputs a data signal (e.g., 751) to an amplifier 795 andan inverting amplifier 797. In some examples, both amplifiers are unitygain amplifiers. In some examples, amplifiers 795, 797 comprisetri-state buffers. In some examples comprising digital signals, theinverting amplifier 797 can comprise a digital NOT gate. The output fromthe amplifier 795 and the inverting amplifier 797 are generally oppositeone another and are directed to the signal processor 720 c.

As described elsewhere herein, in some embodiments, the controller 715and/or the signal generator 713 is configured to encode data fortransmission via the amplifiers 795 and 797. The signal processor 720 ccan include a signal extraction module 734 configured to extract thedata from the signal(s) communicated to the signal processor 720 c toproduce a signal for use by the signal processor 720 c. In someexamples, the signal extraction module 734 is capable of decoding thesignal that was encoded by the implantable battery and/or communicationmodule 710 c. Additionally or alternatively, the signal extractionmodule 734 can extract a signal resulting from the lead transferfunction. In various examples, the extracted signal can include, forexample, an updated transfer function for the signal processor 720 c, adesired stimulation command, or other signals that affect operation ofthe signal processor 720 c.

In the example of FIG. 7C, similar to signal extraction module 724 inFIG. 7B, the signal extraction module 734 includes a pair of tri-statebuffers 787 and 789 in communication with signals output from the signalgenerator 713. The tri-state buffers 787 and 789 are shown as having“enable” (ENB) signals provided by controller 727 in order to controloperation of the tri-state buffers 787 and 789 for extracting the signalfrom the signal generator 713. Signals from the signal generator 713 andbuffered by tri-state buffers 787 and 789 are received by amplifier 785,which can be configured to produce a signal representative of the signalgenerated by the signal generator 713.

As described elsewhere herein, in some examples, communication ofsignals generated at the signal generator 713 can be communicated to thesignal processor 720 c at a clock rate that is different from the clockrate of the signals generated by the power signal generator 711. Forinstance, in some embodiments, power signals from the power signalgenerator 711 are transmitted at approximately 30 kHz, which can be anefficient frequency for transmitting power. However, in some examples,the signals from the signal generator 713 are transmitted at a higherfrequency than the signal from the power signal generator 711, forexample, at approximately 1 MHz. Such high frequency data transmissioncan be useful for faster data transfer than would be available at lowerfrequencies (e.g., the frequencies for transmitting the signal from thepower signal generator 711). Thus, in some embodiments, power and datacan be communicated from the implantable battery and/or communicationmodule 710 c to the signal processor 720 c via different communicationchannels at different frequencies.

In the illustrated example of FIG. 7C, the signal processor 720 cincludes a signal generator 717 and controller 727 that is incommunication with the signal generator 717. Similar to the operation ofsignal generator 713 and amplifiers 795 and 799, the signal generatorcan be configured to produce output signals to buffers 787 and 789,which can be configured to output signals to the implantable batteryand/or communication module 710 c.

In some embodiments, the controller 727 in the signal processor 720 c iscapable of monitoring the DC power 723 and/or the signal received fromthe implantable battery and/or communication module 710 c. Thecontroller 726 can be configured to analyze the received DC power 723and the signal and determine whether or not the power and/or signal issufficient. For example, the controller 727 may determine that thesignal processor 720 c is receiving insufficient DC power forstimulating a cochlear electrode according to the signal processor 720 ctransfer function, or that data from the implantable battery and/orcommunication module 710 c is not communicated at a desired rate. Thus,in some examples, the controller 727 of the signal processor 720 c causethe signal generator 717 to generate communication signals to send toimplantable battery and/or communication module 710 c. Such signals canbe used to provide feedback regarding signals received by the signalprocessor 720 c, such as the DC power 723.

In the example of FIG. 7C, amplifiers 795 and 797 are shown as includingtri-state amplifiers (e.g., tri-state buffers) controllable by thecontroller 727. Similar to the configuration in the signal processor 720c, the implantable battery and/or communication module 710 c includes asignal extraction module 735 configured to extract data from thesignal(s) communicated to the implantable battery and/or communicationmodule 710 c from signal generator 717 of the signal processor 720 c.The signal extraction module 735 includes amplifiers 795 and 797 (e.g.,tri-state buffers) in communication with signals output from the signalgenerator 717. Signals from the signal generator 717 and received atamplifiers 795 and 797 are received by amplifier 799, which can beconfigured to produce a signal representative of the signal generated bythe signal generator 717 to controller 715 of the implantable batteryand/or communication module 710. Thus, in some embodiments, thecontroller 727 of the signal processor 720 c is configured tocommunicate data back to the implantable battery and/or communicationmodule 710 a via buffers 787 and 789.

As described with respect to other embodiments, based on the receivedfeedback from the controller 727 of the signal processor 720 c, thecontroller 715 of the implantable battery and/or communication module710 c can adjust various properties of the signals output by the powersignal generator 711 and/or the signal generator 713.

Thus, in the illustrated example of FIG. 7C, bidirectional communicationsignal 751 between the implantable battery and/or communication module710 c and signal processor 720 c includes communication betweendifferent signal extraction modules 735 and 734. As shown, both theimplantable battery and/or communication module 710 c and the signalprocessor 720 c include a controller (715, 727) that communicates with asignal generator (713, 717) for producing output signals. The signalgenerator (713, 717) outputs signals via tri-state amplifiers, includingone inverting amplifier (797, 789) for communication acrossbidirectional communication 751 c for receipt by the other signalextraction module (734, 735).

Thus, in some embodiments, bidirectional communication 751 c between theimplantable battery and/or communication module 710 c and the signalprocessor 720 c can be enabled by each of the implantable battery and/orcommunication module and the signal processor receiving and transmittingdata via approximately the same communication structure as the other. Insome such examples, the implantable battery and/or communication module710 c and the signal processor 720 c include signal extraction modules735 and 734, respectively, configured both to output signals from asignal generator (e.g., via signal generator 713 or signal generator717) and receive and extract signals (e.g., via amplifier 785 andamplifier 799).

In the example of FIG. 7C, amplifiers 795 and 797 comprise tri-stateamplifiers that selectively (e.g., via “enable” control from controller715) output the signal from signal generator 713, and amplifier 797 isshown as an inverting amplifier. As described, in some examples,amplifiers 795 and 797 comprise tri-state buffers. Similarly, oftri-state buffers 787 and 789 that selectively (e.g., via “enable”control from controller 727) output the signal from signal generator717, buffer 789 is shown as an inverting amplifier. As describedelsewhere herein, communicating a signal and its inverse (e.g., via 795and 797) allows communication with no net charge flow between theimplantable battery and/or communication module 710 c and the signalprocessor 720 c. Thus, bidirectional communication between theimplantable battery and/or communication module 710 c and the signalprocessor 720 c can be performed without a net charge flow between thecomponents.

As described elsewhere herein, power from power generator 711 and datafrom signal generator 713 (and/or signal generator 717) can becommunicated at different clocking rates to optimize power and datatransfer. In some examples, if data communication (e.g., viabidirectional communication 751 c) fails, the controller 715 can beconfigured to control power generator 711 to provide both power and datasignals via amplifiers 790 and 792, for example, as described withrespect to FIG. 6B.

Accordingly, in some embodiments, the configuration of FIG. 7C can beimplemented to establish efficient, bidirectional communication betweenthe implantable battery and/or communication module 710 and the signalprocessor 720. Failure in bidirectional communication 751 can beidentified manually and/or automatically. Upon detection of failure inthe bidirectional communication 751, the controller 715 can encode datainto the power signal output from the power signal generator 711, andpower and data can be combined into a single signal such as describedwith respect to FIG. 6B.

As discussed elsewhere herein, different safety standards can existregarding electrical communication within the patient's body. Forexample, safety standards can limit the amount of current that cansafely flow through a patient's body (particularly DC current). As shownin FIGS. 6B, 7B, and 7C, each of the illustrated communication pathsbetween the implantable battery and/or communication module and thesignal processor are coupled to output capacitors. The capacitorspositioned at the inputs and outputs of the implantable battery and/orcommunication module and the signal processor can substantially block DCcurrent from flowing therebetween while permitting communication of ACsignals.

As described elsewhere herein, in some embodiments, the datacommunicated between the implantable battery and/or communication moduleand the signal processor (e.g., from the signal generator) is encoded.In some such examples, the encoding can be performed according to aparticular data encoding method, such as an 8 b/10 b encoding scheme, toachieve DC balance in the communicated signal. For example, in someembodiments, data is encoded such that the numbers of high and low bitscommunicated between components at each clock signal meet certaincriteria to prevent a charge of a single polarity from building up onany of the capacitors. Such encoding can minimize the total charge thatflows between the implantable battery and/or communication module andthe signal processor during communication.

While described and illustrated as representing communication betweenthe implantable battery and/or communication module and the signalprocessor, it will be appreciated that communication configurations suchas shown in FIGS. 5A, 5B, 6A, 6B, 7A, 7B, and 7C can be implementedbetween any pair of devices generally in communication with one another.For example, isolating circuitry (e.g., R_(Can)) can be included in anyof the system components (e.g., middle ear sensor, acoustic stimulator,electrical stimulator, etc.) to effectively isolate the ground signalsfrom each component from its respective can. Similarly, the exemplarycapacitive AC coupling with DC blocking capacitors and DC balancingencoding as described elsewhere herein can be incorporated as thecommunication interface between any two communicating components.

As described, data can be communicated from the implantable batteryand/or communication module to the signal processor for a variety ofreasons. In some examples, data is that communicated to the implantablebattery and/or communication module from an external device, such as aprogrammer as shown in FIG. 1 . In an exemplary process, a programmer,such as a clinician's computer, can be used to communicate with apatient's fully implanted system via a communication configuration suchas shown in FIGS. 6B, 7B, or 7C. For example, a programmer cancommunicate wirelessly (e.g., via Bluetooth or other appropriatecommunication technique) with the patient's implantable battery and/orcommunication module. Signals from the programmer can be sent from theimplantable battery and/or communication module to the signal processorvia the communication configurations of FIGS. 6B, 7B, or 7C.

During such processes, a clinician can communicate with the signalprocessor, and, in some cases, with other components via the signalprocessor. For example, the clinician can cause the signal processor toactuate an electrical and/or an acoustic stimulator in various ways,such as using various electrical stimulation parameters, combinations ofactive contact electrodes, various acoustic stimulation parameters, andvarious combinations thereof. Varying the stimulation parameters in realtime can allow the clinician and patient to determine effectiveness ofdifferent stimulation techniques for the individual patient. Similarly,the clinician can communicate with the signal processor to updatetransfer function. For example, the clinician can repeatedly update thetransfer function signal processor while testing the efficacy of eachone on the individual patient. In some examples, combinations ofstimulation parameters and signal processor transfer functions can betested for customized system behavior for the individual patient.

In some embodiments, various internal properties of the system may betested. For instance, various impedance values, such as a sensorimpedance or a stimulator impedance can be tested such as described inU.S. Patent Publication No. 2015/0256945, entitled TRANSDUCER IMPEDANCEMEASUREMENT FOR HEARING AID, which is assigned to the assignee of theinstant application, the relevant portions of which are incorporated byreference herein.

Additionally or alternatively, various characteristics of individualleads can be analyzed. FIG. 7D is high-level schematic diagramillustrating exemplary electrical communication between an implantablebattery and/or communication module and a signal processor in a cochlearimplant system similar to that shown in FIG. 7A. In the simplifiedexample of FIG. 7D, conductors 701, 702, 703, and 704 extend betweenimplantable battery and/or communication module 710 d and signalprocessor 720 d. In some examples, such conductors are included in alead (e.g., lead 190) extending between the implantable battery and/orcommunication module 710 d and signal processor 720 d. In the example ofFIG. 7D, implantable battery and/or communication module 710 d includescontroller 705 and signal processor 720 d includes controller 706. Otherinternal components of the implantable battery and/or communicationmodule 710 d and signal processor 720 d are not shown, though variousconfigurations are possible, such as shown in FIGS. 6B, 7B, or 7C.

In some embodiments, one or both of controllers 705, 706 can beconfigured to apply a test signal to one or more of conductors 701, 702,703, 704 in order to test one or more properties of such conductors. Inan exemplary test process, a controller (e.g., 705) can drive a signal(e.g., a sine wave or other shaped wave) across a conductor (e.g., 701)and measure the sent current and the voltage at which the current issent. From this information, the controller can determine conductorimpedance, including integrity of the conductor (e.g., whether or notthe conductor is broken). Similarly, a controller can be configured toground a second conductor (e.g., 702) while driving the test signalacross a test conductor (e.g., 701) in order to measure one or moreelectrical parameters between the two conductors (e.g., capacitance,impedance, etc.).

During exemplary operation, a controller can be configured to apply atest signal to a first conductor (e.g., 701) and ground a secondconductor (e.g., 702). The controller can be configured to apply a testsignal at a plurality of frequencies (e.g., perform a frequency sweep)and measure impedance vs. frequency between the first conductor and thesecond, grounded conductor. In various examples, a controller can beconfigured to perform such tests using any two conductors 701, 702, 703,704, to test for baseline values (e.g., when the system is in a knownworking condition) or to test for expected values (e.g., to compare toan established baseline). In different embodiments, the controller inthe implantable battery and/or communication module 710 d (controller705) and/or the controller in the signal processor 720 d (controller706) can perform the grounding of one or more conductors and/or applythe test signal to one or more conductors.

In some embodiments, such test processes can be performed automatically,for example, according to a programmed schedule. Additionally oralternatively, such test processes can be initiated manually, forexample, by a wearer or a clinician, via an external device such as viaa programmer (e.g., 100) or charger (e.g., 102). The results of suchprocesses can be stored in an internal memory for later access andanalysis, and/or can output to an external device for viewing. In someexamples, results and/or a warning can be output to an external deviceautomatically in the event that one or more results deviatessufficiently from a baseline value. In various examples, sufficientvariation from the baseline for triggering an output can be based on apercent variation from the baseline (e.g., greater than 1% deviationfrom be baseline, greater than 5% deviation, greater than 10% deviation,etc.). Additionally or alternatively, sufficient variation an includevarying a certain number of standard deviations from the baseline (e.g.,greater than one standard deviation, two standard deviations, etc.). Invarious embodiments, the amount of variation that triggers outputtingthe results and/or a warning is adjustable. Additionally oralternatively, such an amount can vary between different measurements.

In some embodiments, one or more actions may be performed in response tothe results of such an analysis. For instance, in an exemplaryembodiment described with respect to FIG. 7B, if a test reveals anunexpected impedance on one of the signal conductors (e.g., fromamplifier 794 or inverting amplifier 796), such as an open circuit, thecontroller 714 may be configured to change operation of the system. Forinstance, controller 714 can be configured to adjust the output frompower generator 711 in order to provide both power and data signals fromthe power generator 711, such as described with respect to theconfiguration in FIG. 6B. In some examples, the controller 714 can beconfigured to transmit a signal to an external device signaling such achange in operation and/or alerting a wearer and/or clinician that oneor more conductors may be damaged or otherwise not operational.

While shown in several embodiments (e.g., FIGS. 1, 4, 6A, 7A) as beingseparate components connected by a lead (e.g., lead 180), in someexamples, the processor (e.g., 120) and the stimulator (e.g., 130) canbe integrated into a single component, for example, within ahermetically sealed housing. Some such embodiments are described in U.S.patent application Ser. No. 16/797,388, filed Feb. 21, 2020, and whichis assigned to the assignee of the instant application and isincorporated herein by reference.

As described elsewhere herein, while many examples show a middle earsensor being in communication with an implanted signal processor, invarious embodiments, one or more additional or alternative input sourcescan be included. For instance, in some embodiments, a microphone can beimplanted under a user's skin and can be placed in communication withthe signal processor (e.g., via a detachable connector such as 171). Thesignal processor can receive input signals from the implanted microphoneand provide signals to the stimulator based on the received input signaland the signal processor transfer function.

Additionally or alternatively, one or more system components can beconfigured to receive broadcast signals for converting into stimulationsignals. FIG. 8 is a schematic system diagram showing an implantablesystem configured to receive broadcast signals from a broadcast device.As shown in the example of FIG. 8 , a broadcast source 850 broadcasts asignal via communication link 860. The communication link 860 caninclude communication via a variety of communication protocols, such asWi-Fi, Bluetooth, or other known data transmission protocols. Broadcastsource 850 can include any of a variety of components, such as a mediasource (e.g., television, radio, etc.), communication device (e.g.,telephone, smartphone, etc.), a telecoil or other broadcast system(e.g., at a live performance), or any other source of audio signals thatcan be transmitted to an implanted system or to an external device of animplanted system (e.g., a system programmer, etc.).

An implantable system including a programmer 800, an implantable batteryand/or communication module 810, a signal processor 820, and astimulator 830 can generally receive the data from the broadcast source850 via communication link 860. In various embodiments, any number ofcomponents in the implantable system can include a receiving device,such as a telecoil, configured to receive broadcast signals for eventualconversion into stimulation signals.

For instance, in some embodiments, programmer 800 can include a telecoilrelay configured to receive broadcast telecoil signals from a broadcastsource 850. The programmer can be configured to subsequently communicatea signal representative of the received broadcast signal to theimplantable battery and/or communication module 810 and/or the signalprocessor 820, e.g., via a Bluetooth communication. If the communicationis received from the programmer 800 via the implantable battery and/orcommunication module 810, the implantable battery and/or communicationmodule 810 can communicate the signal to the signal processor, forexample, as described in any of FIGS. 6A, 6B, 7A, or 7C.

In some such embodiments, the signal processor 820 can be configured toreceive such signals from the implantable battery and/or communicationmodule 810 and output stimulation signals to the stimulator 830 based onthe received signals and the signal processor transfer function. Inother examples, the signal processor 820 can include a telecoil relay orother device capable of receiving broadcast signals from the broadcastsource 850. In some such embodiments, the signal processor 820 processesthe received signals according to the signal processor transfer functionand outputs stimulations signals to the stimulator 830.

In some embodiments, the signal processor 820 can be in communicationwith a plurality of input sources, such as, for example, a combinationof an implanted microphone, a middle ear sensor, and a broadcast source850 (e.g., via the implantable battery and/or communication module 810).In some such examples, the signal processor can be programmed with aplurality of transfer functions, each according to respective inputsources. In such embodiments, the signal processor can identify whichone or more input sources are providing input signals and process eachsuch input signal according to the transfer function associated with itscorresponding input source.

In some examples, a signal processor 820 receiving a plurality of inputsignals from a corresponding plurality of input sources effectivelycombines the signals when producing a stimulation signal to thestimulator 830. That is, in some embodiments, input sources are combinedto form the stimulation signal from the signal processor 820. In somesuch examples, a user may be able to mix the various received inputsignals in any way desired. For example, a user may choose to blend avariety of different input streams, such as an input from a middle earsensor or other implanted device, a signal received from an externaldevice (e.g., a telecoil relay, a Bluetooth connection such as to asmartphone, etc.), and the like. In an exemplary configuration, a usermay elect to equally blend two input sources such that the stimulationsignal is based 50% on a first input source and 50% on a second inputsource.

Additionally or alternatively, a user may elect to effectively “mute”one or more input sources so that the signal processor 820 outputsstimulations signals based on input signals received from unmutedsources. Similarly, a user may be able to select a single source fromwhich to process received input signals. For example, in someembodiments, a user may select to have signals received from broadcastsource 850 processed and converted into stimulation signals while havingsignals received from, for example, a middle ear sensor, disregarded.

In some examples, direct communication with the signal processor can beused to test the efficacy of a given signal processor transfer functionand associated stimulation (e.g., acoustic or electrical) parameters.For example, the programmer can be used to disable input signals from amiddle ear sensor or other input source and provide a customized signalto the signal processor to simulate a signal from the input source. Thesignal processor processes the received signal according to its transferfunction and actuates the electrical stimulator and/or the acousticstimulator accordingly. The processor can be used to test a variety ofcustomized “sounds” to determine the efficacy of the signal processortransfer function for the given patient for each “sound.”

Various features and functions of implantable systems have beendescribed herein. As described, in various embodiments, systemoperation(s) can be adjusted based on communication with the implantedsystem from components located outside of the body while the systemremains implanted. In some embodiments, the system may include anynumber of external devices capable of interfacing with the system in avariety of ways.

FIG. 9 is a schematic diagram illustrating possible communicationbetween a variety of system components according to some embodiments ofa fully implantable system. In the illustrated embodiment, implantedcomponents (outlined in broken line) of a system include an implantablebattery and/or communication module 910, a signal processor 920, and astimulator 930. Such implanted components can operate according tovarious examples as described herein in order to effectively stimulate auser (e.g.., via electrical and/or acoustic stimulation) in response toreceived input signals.

The schematic illustration of FIG. 9 includes a plurality of externaldevices capable of wirelessly interfacing with one or more of theimplanted components, for example, via communication link 925. Suchdevices can include a programmer 900, a charger 902, a smartphone/tablet904, a smartwatch or other wearable technology 906, and a fob 908. Insome examples, such components can communicate with one or moreimplantable components via one or more communication protocols viawireless communication link 925, such as Bluetooth, Zigbee, or otherappropriate protocols. In various embodiments, different externaldevices are capable of performing one or more functions associated withsystem operation. In some such embodiments, each external device iscapable of performing the same functions as the others. In otherexamples, some external devices are capable of performing more functionsthan others.

For example, a programmer 900 can be capable of interfacing wirelesslywith one or more implantable components in order to control a variety ofoperating parameters of the implanted system. For example, in someembodiments, programmer 900 can be configured to adjust a signalprocessor transfer function or select an operating profile (e.g.,associated with a particular signal processor transfer functionaccording to a particular user, environment, etc.). In some examples,the programmer 900 can be used to establish user profiles, such aspreferred signal processor transfer functions, as described elsewhereherein. The programmer 900 can additionally or alternatively be used toturn the system on or off, adjust the volume of the system, receive andstream input data to the system (e.g., the implantable battery and/orcommunication module 910). In some embodiments, the programmer 900includes a display for displaying various information to the user. Forexample, the display can be used to indicate a mode of operation (e.g.,a loaded user profile), a remaining power level, or the like. In somesuch embodiments, the display can function as a user interface by whicha user can adjust one or more parameters, such as volume, profile, inputsource, input mix, and the like.

In some embodiments, a charger 902 can be used to charge one or moreinternal batteries or other power supplies within the system, such as inthe implantable battery and/or communication module 910. In someexamples, the charger 902 can include the same functionality as theprogrammer 900, including, for instance, a display and/or userinterface. In some such embodiments, the programmer 900 and the charger902 can be integrated into a single device.

In some embodiments, various external devices such as a smartphone ortablet 904 can include an application (“app”) that can be used tointerface with the implanted system. For example, in some embodiments, auser may communicate (e.g., via link 925) with the system via thesmartphone or tablet 904 in order to adjust certain operating factors ofthe system using a predefined app to provide an interface (e.g., avisual interface via a display integrated into the external device). Theapp can assist the user in adjusting various parameters, such as volume,operating profile, on/off, or the like. In some examples, thesmartphone/tablet 904 can be used to stream input signals to theimplanted system, such as media or communication playing on thesmartphone/tablet 904.

In some systems, a smartwatch or other wearable technology 906 caninteract with the system in a similar way as the smartphone/tablet 904.For example, the smartwatch or other wearable technology 906 can includean app similar to that operable on the smartphone/tablet to controloperation of various aspects of the implanted system, such as volumecontrol, on/off control, etc.

In some embodiments, the fob 908 can be used to perform basic functionwith respect to the implanted system. For instance, in some embodiments,a fob 908 can be used to load/implement a particular operating profileassociated with the fob 908. Additionally or alternatively, the fob 908can function similar to the shut-off controller 104 of FIG. 1 and can beused to quickly disable and/or mute the system. As described elsewhereherein, in some examples, the same device used to disable and/or mutethe system (e.g., fob 908) can be used to enable and/or unmute thesystem.

The schematic diagram of FIG. 9 further includes a broadcast source 950configured to broadcast signals 960 that are receivable via one or moreexternal devices and/or one or more implanted system components. Similarto the broadcast source 850 in FIG. 8 , broadcast source 950 can beconfigured to emit signals that can be turned into stimulation signalsfor application by stimulator 930. Broadcast signals 960 can include,for example, telecoil signals, Bluetooth signals, or the like. Invarious embodiments, one or more external devices, such as a programmer900, charger 902, smartphone/tablet 904, smartwatch/wearable device 906,and/or fob 908 can include a component (e.g., a telecoil relay) capableof receiving broadcast signal 960. The external device(s) can be furtherconfigured to communicate a signal to one or more implanted componentsrepresentative of the received broadcast signal 960 for applyingstimulation to the patient based on the broadcast signal 960.

Additionally or alternatively, in some embodiments, one or moreimplanted system components, such as an implantable battery and/orcommunication module 910, a signal processor 920, and/or a stimulator930 can be configured to receive broadcast signals 960. Suchcomponent(s) can be used to generate stimulation signals for applying toa user via stimulator 930 according to the received broadcast signals960.

As described, in some embodiments, various devices can communicate withcomponents in an implanted system via wireless communication protocolssuch as Bluetooth. Various data and signals can be communicatedwirelessly, including control signals and streaming audio. However, insome cases, such wireless communication should be made secure so that asystem only communicates with those devices desired by the wearer. Thiscan prevent unwanted signals from being broadcast to an implanted deviceand/or unauthorized access to one or more adjustable device settings.

In some embodiments, one or more implanted system components comprises anear field communication component configured to facilitatecommunication between the system and an external device only whenbrought into very close proximity to the near field communicationcomponent. In some such examples, once near-field communication isestablished, the pairing for longer-range wireless communication (e.g.,Bluetooth) can be established. For instance, in an exemplary embodiment,a charger and an implantable battery and/or communication module caneach include near field communication components for establishing asecure, near field communication and subsequently pairing to each otherfor additional wireless communication.

In embodiments wherein the external device includes, or is incommunication with, a microphone, the external device can be configuredto reprogram the signal processor based on information collected fromthe microphone representative of the acoustic environment. For example,the external device can be configured to identify background noise (e.g.low-end noise) and update the signal processor transfer functionaccordingly. In some such examples, the external device can beconfigured to reduce gain for low-end signals and/or emphasize othersounds or frequency ranges, such as speech or other sounds having ahigher frequency. In some embodiments, a user can initiate the processof identifying background noise for adjusting the operation of thesignal processor via the external device, for example, via a userinterface (e.g., a smartphone or tablet touchscreen).

In embodiments in which the external device includes or is incommunication with a location sensor and/or a clock, the external devicemay reprogram the signal processor based on a detected location and/ortime. For instance, in an example embodiment, when the external deviceis located in a place known to be loud (e.g. a mall or sports stadium),the external device can be configured to detect the location andautomatically reprogram the signal processor to reduce background noise(e.g., a particular frequency or range of frequencies) and/or reduce theoverall gain associated with the transfer function. Similarly, in someexamples, when located in a place in which a wearer may wish toparticularly recognize speech (e.g., a movie theater) the externaldevice can be configured to reprogram the signal processor to emphasizefrequencies associated with speech.

In some examples, the transfer function can be updated to reduce acontribution of identified background noise. In some embodiments,reducing a contribution of identified background noise comprisesemphasizing signals having frequency content between approximately 200Hz and 20 kHz. In some such examples, updating the transfer function toreduce a contribution of the identified background noise comprisesemphasizing signals having frequency content between approximately 300Hz and 8 kHz. Emphasizing signals in such frequency ranges can helpemphasize human speech or other similar signals within a noisyenvironment.

Additionally or alternatively, the external device can be configured toreprogram the signal processor based on a determined time of day. Forexample, at times when the wearer generally doesn't want to be bothered(e.g. at night), the external device can be configured to lower thevolume of all or most sounds. In some examples, the wearer mayadditionally or alternatively temporarily reprogram the signal processorvia the external device to adjust the transfer function of the signalprocessor (e.g., to reduce volume) for a predetermined amount of time(e.g. 15 minutes, 1 hour, or 1 day).

In some examples, reprogramming the signal processor comprises adjustingthe transfer function to effect a relative change (e.g., reduce volume).In some cases, reprogramming the signal processor comprises implementinga predefined transfer function in response to received data, such aslocation data indicating the wearer is in a particular location. In somesuch examples, a plurality of pre-programmed transfer functions arestored in a memory and can be implemented based on data acquired via oneor more sensors of the external device.

In some embodiments, the external device can be configured to provide aninput signal based on audio generated by the external device. Forexample, the external device can be a smartphone, and can provide aninput signal to a wearers implantable battery and/or communicationmodule comprising audio from a phone call, text to speech audio (e.g.reading a text message or an article out loud), and/or media audio (e.g.videos, music, games, etc.). The implantable battery and/orcommunication module can be configured to relay the input signal to thesignal processor for the signal processor to convert into correspondingstimulation signals.

As discussed herein, various devices may be paired to a cochlear implantsystem. For example, FIG. 9 provides a variety of external devices suchas a programmer 900, charger 902, smartphone/tablet 904,Smartwatch/Wearable 906, Fob 908, or the like. Additionally oralternatively, external devices may comprise a remote, a remotemicrophone, an external device that connects to a TV or other AVcomponents for streaming audio to a cochlear implant, or the like.Several examples of external devices are described herein.

In some embodiments, a user (e.g. a physician, audiologist, or the like)may manually pair various external devices with an implantable cochlearimplant system. However when pairing multiple external devices, theprocess may become burdensome for the user.

FIG. 10 shows an illustration of an example pairing system that can beused to facilitate pairing one or more external devices with animplantable cochlear implant system. Such a pairing system can be usedto place multiple external devices into communication with a programmingdevice, which can pair each of the external devices with an implantablecochlear implant system.

As shown in the example of FIG. 10 , the pairing system 1000 comprisesan external pairing device 1060 which can be used to facilitate thepairing of one or more external devices 1036A-E with a cochlear implantsystem, such as the fully implantable cochlear implant systems shown inFIGS. 1 and 4 . The exemplary pairing device may further include aplurality of near field communication devices 1066A-E. Near fieldcommunication devices 1066A-E can include, for example, coils that canbe configured to communicate and provide electrical power wirelessly.

In some examples, external pairing device 1060 can include a mat, atabletop, a box, or the like which can provide a relatively flat surfaceupon which the one or more external devices 1036A-E can be placed, suchas the top or side surface of the external pairing device. In someembodiments, each of the near field communication devices 1066A-E may belocated beneath such a surface such that one or more external devicespositioned on the surface may be positioned proximate a near fieldcommunication device and communicate therewith.

Near field communication devices 1066A-E can be configured to providecommunication between a programming device 1072 and the one or moreexternal devices 1036A-E. Programming device 1072 can be configured tocommunicate with the one or more external devices 1036A-E, for example,to enable communication between such external device(s) and an implantedcochlear implant system as described elsewhere herein. In someembodiments, programming device 1072 can include a computer, tablet,smartphone, or other device. In the illustrated example, externalpairing device 1060 is in communication with programming device 1072 viaa wired connection 1082. As shown, in the example of FIG. 10 , each nearfield communication device 1066A-E has a lead extending from the deviceto wired connection 1082. In some examples, the wired connection 1082from the external pairing device is configured to provide parallelcommunication between each of the near field communication devices andthe programming device 1072. For example, in some embodiments, aprogramming device can be in communication with each of a plurality ofexternal devices (e.g., 1036A-E) simultaneously. In other examples,external pairing device 1060 includes an electronics module configuredto multiplex communications between each of the near field communicationdevices 1066A-E and the programming device 1072. In some suchembodiments the programming device 1072 can communicate with each of thenear field communication devices 1066A-E individually and cancommunicate with a plurality of near field communication devicessequentially. Additionally or alternatively, in some examples, externalpairing device 1060 can be configured to communicate wirelessly withprogramming device 1072, such as via a Bluetooth or other wirelesscommunication.

In some embodiments, communication between the programming device 1072and the one or more external devices 1036A-E is established when the oneor more external devices 1036A-E are located adjacent to a correspondingnear field communication device 1066A-E.

In some embodiments, an external housing 1030 may be used to house theone or more external devices 1036A-E and assist in placing the one ormore external devices 1036A-E adjacent to the one or more correspondingnear field communication devices 1066A-E. In some embodiments, theexternal housing 1030 may comprise any object which can house one ormore external devices 1036A-E, such as a box, a briefcase, variouscontainers, or the like.

In some embodiments, the external housing 1030 may comprise one or morecompartments 1034A-E. As illustrated in FIG. 10 , each of the one ormore compartments 1034A-E may comprise a similar geometrical shape.Alternatively, the one or more compartments may comprise a variety ofgeometrical shapes. In some embodiments, one or more of the one or morecompartments 1034A-E may be shaped to receive a unique correspondingexternal device. In such embodiments, the compartments may compriseindicia, such as labels, notifying a user which unique external deviceshould be placed in said compartment.

In some embodiments, the external housing 1030 may comprise at least onerelatively flat surface proximate the one or more compartments 1034A-Ethat can be placed adjacent to a similarly flat surface of the externalpairing device 1060. For instance, in some examples, the externalhousing 1030 includes a first surface 1032 configured to engage a secondsurface 1062 included on the external pairing device 1060.

As shown in FIG. 10 , the compartments 1034A-E may be arranged in apattern to facilitate alignment of one or more external devices (e.g.external devices 1036A-E) with a corresponding one or more near fieldcommunication devices (e.g. near field communication devices 1066A-E ofthe external pairing device 1060). Such alignment can result in each ofthe one or more external devices 1036A-E being positioned near enough toa corresponding one of the near field communication devices 1066A-E toestablish communication with the corresponding near field communicationdevice. Established communication between an external device (e.g.,1036A) and a corresponding near field communication device (e.g., 1066A)can result in established communication between the external device(e.g., 1036A) and the programming device 1072 via the near fieldcommunication device (e.g., 1066A).

In some embodiments, each of the one or more compartments 1034A-E may bearranged in a first configuration such that each of the one or morecompartments 1034A-E has a unique position within the external housingrelative to the first surface 1032. In some examples, each of the one ormore near field communication devices 1066A-E is arranged in acorresponding configuration relative to the second surface 1062 of theexternal pairing device 1060. The corresponding configuration can besuch that each of the one or more near field communication devices1066A-E of the external pairing device 1060 can be simultaneouslyaligned with a corresponding compartment 1034A-E of the external housing1030. Similarly, each of one or more external devices 1036A-E within acorresponding compartment 1034A-E can simultaneously align with acorresponding one of the one or more near field communication devices1066A-E.

Additionally or alternatively, in some embodiments, indicia or othermarkings may be used to assist in providing a correct alignment betweenthe one or more compartments 1034A-E and corresponding near fieldcommunication devices 1066A-E. For example, indicia 1068 can be presenton the second surface 1062 of the external pairing device 1060 torepresent a location and an orientation for positioning the externalhousing 1030 for correct alignment. Other markings may include indiciaon the external housing 1030, bumps or indentations to provideinformation on a location and orientation for positioning the externalhousing 1030, or the like.

In addition to facilitate pairing, the external pairing device 1060 mayalso be configured to electronically charge one or more external devices1036A-E. For example, the external pairing device 1060 can provideelectrical power to one or more external devices 1036A-E viacorresponding near field communication devices 1066A-E when an externaldevice 1036A-E is aligned with a corresponding near field communicationdevice 1066A-E. As described elsewhere herein, a near fieldcommunication device (e.g., 1066A) can comprise a coil configured tofacilitate communication with and charging of a corresponding externaldevice (e.g., 1036A). In various embodiments, electrical power can beprovided via the programming device (e.g., via USB connection) and/or anexternal power source, such as from a wall receptacle, USB port, or thelike. In some examples, each near field communication device can includea corresponding drive circuit configured to provide an AC signal to thenear field communication device even if receiving power from a DC powersource.

In some examples, every near field communication device is able toprovide electrical power to charge a corresponding external devicesimultaneously regardless of which or how many external devices are incommunication with the programming device 1072. Some such examplesinclude a connection to a separate power source, such as a wall outlet.In other examples, only those devices in communication with theprogramming device 1072 receive electrical power, for example, from theprogramming device 1072 itself

While generally described herein with respect to cochlear implantsystems (e.g., fully implantable cochlear implant systems), it will beappreciated that configurations such as those shown in FIG. 10 can beused in a variety of applications. In general, an external pairingdevice including a plurality of near field communication devices can beused to charge and/or communicate with a plurality of devices within anexternal housing arranged in a configuration corresponding to theconfiguration of the plurality of near field communication devices. Suchsystems can be used, for example, to pair each of the plurality ofdevices to a wireless device. This can be useful when the wirelessdevice does not have an interface via which a user can initiate pairingwith the wireless device itself and/or when a plurality of devices areto be paired with the wireless device. Such systems can be implemented,for example, in a medical device context, such as when one or moreexternal devices are to be paired (e.g., placed into wirelesscommunication) with an implanted medical device.

FIG. 11 shows an example illustration of how a programming device andexternal pairing device can be used to establish a connection between anexternal device and an implanted cochlear implant system. Forsimplicity, FIG. 11 illustrates a single external device 1136, however,in various embodiments, a plurality of external devices andcorresponding near field communication devices can be used, for example,as described with respect to FIG. 10 and elsewhere herein. As shown inFIG. 11 , external device 1136 may establish communication with a nearfield communication device 1166 of an external pairing device 1160 via afirst wireless communication link 1181 a, for example, as discussed withrespect to FIG. 10 and elsewhere herein. In some embodiments, near fieldcommunication device 1166 can include a coil configured to communicatewirelessly with a corresponding coil in the external device 1136.

In some embodiments, the near field communication device 1166 can beconnected to a programming device (e.g. programming device 1172), shownin FIG. 11 via communication link 1181 b. While shown as being a wiredconnection in FIG. 11 , in various embodiments, communication link 1181b can include a wired or wireless communication link. In someembodiments, the programming device 1172 may be in communication withthe external device 1136 through external pairing device 1160 and nearfield communication device 1166 (e.g., via communication link 1181 b andwireless communication link 1181 a).

Additionally or alternatively, in some embodiments, the programmingdevice 1172 may communicate directly with external device 1136, such asvia a wireless communication link. In such embodiments, external pairingdevice 1160 may help facilitate initiating the communication betweenexternal device 1136 and programming device 1172. For example, in someembodiments, near field communication between external device 1136 andprogramming device 1172 (via the external pairing device 1160 andwireless communication link 1181 a) can be used to enable additionalwireless communication (e.g., Bluetooth communication) between theprogramming device 1172 and the external device 1136, for example, asdescribed in U.S. patent application Ser. No. 16/797,396, filed Feb. 21,2020, which is assigned to the assignee of the instant application andis incorporated by reference.

In some embodiments, once communication is established between theprogramming device 1172 and the external device 1136 (e.g. via nearfield communication device 1166 of external pairing device 1160), theprogramming device 1172 may be configured to enable communicationbetween the external device 1136 and an implanted cochlear implantsystem 1180 such as those systems described herein (e.g., a fullyimplantable cochlear implant system such as shown in FIGS. 1 and 4 ).

Enabling communication between the external device 1136 and theimplanted cochlear implant system 1180 may comprise providinginformation to the external device 1136 to allow communication betweenthe external device 1136 and the implanted cochlear implant system 1180to be established, such as via communication link 1182. In someembodiments, the programming device 1172 can be configured tocommunicate information to the external device 1136 to facilitatewireless communication (e.g., Bluetooth communication) between theexternal device 1136 and one or more components of the implantedcochlear implant system 1180 (e.g., an implantable battery and/orcommunication module 1140).

As shown in FIG. 11 , the implanted cochlear implant system 1180comprises an implantable battery and/or communication module 1140configured to communicate with external sources (e.g. external device1136, programming device 1172, or the like). In some embodiments, theimplantable battery and/or communication module 1140 may be configuredto send and/or receive wireless communication signals, such as viacommunication links 1182 and/or 1183. In various examples, wirelesscommunication links 1182 and 1183 may comprise a wireless connectionsuch as a Bluetooth connection, a Wi-Fi connection, or the like.Accordingly, in some such examples, information provided to the externaldevice 1136 to enable communication between the external device 1136 andthe implanted cochlear implant system 1180 can be information enablingBluetooth or other wireless communication between an implantable batteryand/or communication module 1140 and the external device 1136.

In some examples, programming device 1172 can communicate a password orother key to the external device 1136 to enable communication withimplanted cochlear implant system 1180. Additionally or alternatively,programming device 1172 can communicate identification information tothe external device 1136 identifying the implanted cochlear implantsystem 1180 for which communication is being enabled. Suchidentification information can include, for example, a media accesscontroller (MAC) address for the implanted cochlear implant system 1180.

Additionally or alternatively, enabling communication between theexternal device 1136 and the implanted cochlear implant system 1180 maycomprise providing information to the implanted cochlear implant system1180, such as via communication link 1183, to allow communicationbetween the implanted cochlear implant system 1180 and the externaldevice 1136.

In some embodiments, the communicating information from the programmingdevice 1172 to the external device 1136 to enable communication with theimplanted cochlear implant system 1180 is performed in response to auser input to the programming device. For instance, in some examples,programming device 1172 includes a user interface via which a user caninput information corresponding to the implanted cochlear implant system1180 for which communication is to be enabled. In some such embodiments,the programming device 1172 includes a database of identifyinginformation by which a user can select the implanted cochlear implantsystem 1180 for which to enable communication from the database. Forexample, the programming device 1172 can include fitting software withinformation associating an implanted cochlear implant system 1180 to itswearer, and a user (e.g., an audiologist) can enable communication withthe implanted cochlear implant system 1180 by selecting the wearer'ssystem within such a database.

Additionally or alternatively, in some examples, the programming device1172 can be configured to receive information from the implantedcochlear implant system 1180 (e.g., via communication link 1183). Suchinformation can be used by the programming device to communicate thenecessary information to the external device 1136 to enablecommunication with the implanted cochlear implant system 1180.

In some embodiments, once information is provided (e.g.- via programmingdevice 1172) to enable communication between the external device 1136and the implanted cochlear implant system 1180, information enablingcommunication is saved in a memory (e.g., in the external device 1136and/or the implanted cochlear implant system 1180). In such examples,subsequent communications between the external device 1136 and theimplanted cochlear implant system 1180 can be established withoutrequiring external pairing device 1160 or programming device 1172.Alternatively, subsequent communications between the external device1136 and the implanted cochlear implant system 1180 may need to bere-enabled by the external pairing device or a similar device.

FIG. 12 illustrates an exemplary method for establishing a connectionbetween an external device and an implantable cochlear implant system asdiscussed herein. Initially, the one or more external devices (e.g.external devices 1036A-E) may be placed proximate an external pairingdevice (e.g. external pairing device 1060). In some embodiments, asshown in step 1210, such a step may comprise positioning an externalhousing (e.g. external housing 1030) comprising the one or more externaldevices in compartments (e.g. compartments 1034A-E) proximate anexternal pairing device (e.g. external pairing device 1060). The methodfurther includes establishing communication between the one or moreexternal devices (e.g. external devices 1036A-E) and the externalpairing device, such as via the one or more near field communicationdevices (e.g. near field communication devices 1066A-E) (1220). Asdiscussed herein, establishing communication between external devicesand the external pairing device can include aligning each of the one ormore external devices with a corresponding near field communicationdevice of the external pairing device.

After communication is established, the method further includescommunicating information from a programming device (e.g., 1172) to theexternal device(s) via the external pairing device (1230). For instance,in some embodiments, information may be communicated to the one or moreexternal devices using a connection between the one or more externaldevices and the external pairing system, such as via the correspondingnear field communication device. Additionally or alternatively,information may be communicated using other means, such as directly fromthe programming device to the implanted system.

The method shown in FIG. 12 further includes enabling communicationbetween one or more external devices and the implant system (1240). Insome embodiments, the information communicated in step 1230 may compriseinformation to enable communication between the one or more externaldevices and the implantable cochlear implant system as describedelsewhere herein.

As described, in some examples, an external pairing device (e.g.,embodied as a mat with one or more coils embedded therein) can providecommunication between a programming device and one or more externaldevices. In some examples, one or more devices paired to an implantedsystem can be used to subsequently pair additional devices, for example,as described in U.S. patent application Ser. No. 16/797,396, which isincorporated by reference.

FIG. 13 shows a process flow diagram showing an exemplary method forpairing another device with an implanted system using a paired device,in this case, a charger. The method includes selecting an option to paira device to an implant on the charger (step 1300), turning on thedesired device and placing it in a pairing mode (step 1302). The implantdetermines the devices available for pairing and communicates a list ofavailable devices to the charger (step 1304), which displays the list ofavailable devices to a user (step 1306). The user can select from a listof displayed devices to initiate the pairing (step 1308). The chargerand/or selected device can determine if the pairing was successful step(step 1310). If the pairing is successful, a “pair successful” messagecan be displayed via the charger and/or the newly-paired device (step1312). If the pair was unsuccessful, a “pair not successful” message canbe displayed on the charger (step 1314). For example, in someembodiments, after attempting to initiate pairing between an implant(e.g., via the implantable battery and/or communication module of asystem) and another device (e.g., step 1308), if, after a predeterminedamount of time, the charger does not receive an indication confirmingpairing from either the implant or the selected device, the charger maydetermine that the pair was unsuccessful, output the “pair notsuccessful” message (step 1314), and stop attempting to establish thepairing.

In various examples, devices that can be paired to an implant (e.g., forcommunication with an implantable battery and/or communication module)via the charger such as via the method shown in FIG. 13 can include aremote, a smart device running an application for interfacing with theimplant, a fob, an audio streaming device, or other consumer electronicscapable of wireless communication (e.g., Bluetooth).

Accordingly, in some examples, an external pairing device andprogramming device can be used to pair one or more external devices,including a first external device (e.g., a charger), with an implantedsystem. The first external device can later be used to pair additionalexternal devices to the system such as via the process shown in FIG. 13.

As described, in various embodiments, different external devices caninterface with implanted components to adjust operation of the system invarious ways. In some embodiments, not all components are capable ofperforming the same functions as other components. FIG. 14 is a chartshowing the various parameters that are adjustable by each of a varietyof external devices according to some exemplary systems. In the exampleof FIG. 14 , entries in the chart including an ‘X’ represent a componentconfigured to perform a corresponding function. Other examples arepossible in which different components include different functionalitythan is represented by the example of FIG. 14 , for instance, whereincomponents other than or in addition to the charger can initiatewireless pairing with the implanted system.

In the illustrated example of FIG. 14 , some components can beconfigured to broadcast an audio stream to the implanted system, such asvia a Bluetooth connection. For instance, in some embodiments, anexternal audio source can broadcast a wireless signal to an implantedsystem, such as a signal representative of inputs received into theexternal audio source (e.g., from another media device). Additionally oralternatively, systems can include a remote audio pickup having amicrophone or other audio sensing device to receive sounds and tobroadcast a wireless signal representative of the received sounds.

In various examples, one or more devices in the chart of FIG. 14 can beprepackaged in an external housing (e.g., housing 1030 of FIG. 10 ) fordelivery to a wearer. As described elsewhere herein, each such devicecan be located within a corresponding compartment (e.g., 1034A-E) of theexternal housing. The external housing can be positioned proximate apairing device and aligned such that each compartment is proximate acorresponding near field communication device. Each external devicewithin a compartment can be placed into communication with a programmingdevice via the corresponding near field communication device. Theprogramming device can be used to pair such external devices with acochlear implant system, for example, by communicating a MAC addressassociated with the system to each of the external devices.

In some embodiments, a user may select a prepackaged set of externaldevices, for example, from a list of available packages or by creating acustom set of external devices. Such devices can be packaged into anexternal housing by an audiologist or delivered to an audiologist as aprepacked set of external devices. The audiologist can then position theexternal housing on the external pairing device and use the externalpairing device and programming device to pair each external device inthe external housing to a wearer's implanted cochlear implant systemwithout having to remove any device from its packaging. Moreover, asdescribed herein, the near field communication devices of the externalpairing device can be used to provide electrical power to and charge theexternal devices. Accordingly, and audiologist can at least partiallycharge a plurality of external devices and pair such devices to awearer's implanted cochlear implant system without removing any suchdevices from the packaging. The audiologist can show the wearer how theexternal devices work using in-office models while the wearer's externaldevices remain in their packaging.

As described herein, in some embodiments, a first surface (e.g., 1032)of an external housing (e.g., 1030) and a corresponding second surface(e.g., 1062) of an external pairing device (e.g., 1060) can both beflat. In some such examples, the flat first surface of the externalhousing can be placed on the second flat surface of the external pairingdevice to enable communication between one or more external devices anda programming device as discussed herein. Similarly, in some examples,the external pairing device can be placed on top of the external housingto similarly establish communication between one or more externaldevices and a programming device.

In some examples, the first surface and second surface need not be flat.For instance, in some embodiments, at least one of the first surface1032 and the second surface 1062 can comprise various textures and/orgeometrical features, such as angled or curved surfaces. In some suchexamples, the first and second surface can include complementary shapessuch that the compartments arranged in unique positions relative to thefirst surface are each positioned proximate a corresponding near fieldcommunication device in the second surface when the first and secondsurfaces are aligned.

In various examples, the first and second surface can be generallyhorizontal surfaces, such as a mat comprising the second surface and oneor more coils embedded therein acting as near field communicationdevices and configured to support a box comprising one or morecompartments and the first surface. In other examples, the first andsecond surface need not be configured horizontally. In an exampleembodiment, the second surface can be an approximately vertical surface,and the external housing can be placed adjacent the second surface. Insome such examples, the external housing can be set down on a surfaceother than the first surface such that the first surface on the externalhousing is positioned proximate the second surface. Other configurationsare possible and within the scope of this disclosure.

It will be appreciated that, while generally described herein withrespect to implantable hearing systems, communication techniquesdescribed can be used in a variety of other implantable systems, such asvarious neuromodulation devices/systems, including, for example, painmanagement, spinal cord stimulation, brain stimulation (e.g., deep brainstimulation), and the like. Techniques described herein can be used forpairing external devices to a variety of types of systems, such aspartially and fully implantable systems.

Various non-limiting embodiments have been described. These and othersare within the scope of the following claims.

The invention claimed is:
 1. A pairing system comprising: an externalhousing having: a first surface; and a plurality of compartmentsarranged in a first configuration such that each of the plurality ofcompartments has a unique position within the external housing relativeto the first surface; and wherein each of the plurality of compartmentsis configured to house an external device capable of wirelesslyinterfacing with a cochlear implant system; an external pairing devicecomprising: a second surface; and a plurality of near fieldcommunication devices arranged in a configuration corresponding to thefirst configuration relative to the second surface such that the firstsurface of the external housing can be aligned with the second surfaceof the external pairing device in such a way that each of the pluralityof near field communication devices aligns with a corresponding one ofthe plurality of compartments of the external housing; and wherein theexternal pairing device is configured to: provide communication betweena programming device and one or more external devices, each containedwithin a different compartment of the external housing, via one or morecorresponding near field communication devices of the external pairingdevice.
 2. The pairing system of claim 1, wherein the external pairingdevice comprises a mat, and the second surface of the external pairingdevice corresponds to a top side of the mat.
 3. The pairing system ofclaim 1, wherein the second surface of the external pairing devicecomprises indicia representing a location and an orientation forpositioning the external housing such that each of the plurality of nearfield communication devices aligns with a corresponding one of theplurality of compartments of the external housing.
 4. The pairing systemof claim 1, wherein the external housing comprises a box.
 5. The pairingsystem of claim 1, wherein the external pairing device is configured toelectrically charge one or more external devices, each contained in acorresponding compartment of the external housing, via a correspondingone or more near field communication device of the external pairingdevice when the external housing is positioned proximate the externalpairing device and each of the plurality of near field communicationdevices aligns with a corresponding one of the plurality of compartmentsof the external housing.
 6. The pairing system of claim 5, wherein: eachnear field communication device comprises a coil configured tofacilitate communication with and charging of an external device withina corresponding compartment and having a corresponding coil.
 7. Thepairing system of claim 1, wherein each of the plurality of compartmentsis shaped to receive a unique corresponding external device.
 8. Thepairing system of claim 1, further comprising: a cochlear implantsystem; a programming device in communication with each of the pluralityof near field communication devices of the external pairing device; andone or more external devices configured to interface with one or morecomponents of the cochlear implant system, each of the one or moreexternal devices positioned within a corresponding one of thecompartments of the external housing and including a near fieldcommunication interface; and wherein the programming device isconfigured to: communicate with each of the one or more external devicesvia corresponding near field communication devices of the externalpairing device; and provide information to each of the one or moreexternal devices to enable communication between each external deviceand the cochlear implant system.
 9. The pairing system of claim 8,wherein the cochlear implant system comprises: a stimulator; a signalprocessor in communication with the stimulator, the signal processorbeing programmed with a transfer function and being configured toreceive one or more input signals and output a stimulation signal to thestimulator based on the received one or more input signals and thetransfer function; and an implantable battery and/or communicationmodule in communication with the signal processor, the implantablebattery and/or communication module; and wherein the programming deviceis configured to: provide information to each of the one or moreexternal devices to enable communication between each external deviceand the implantable battery and/or communication module of the cochlearimplant system.
 10. The pairing system of claim 9 wherein providinginformation to each of the one or more external devices to enablecommunication between each external device and the implantable batteryand/or communication module of the cochlear implant system comprisesenabling Bluetooth communication between each external device and theimplantable battery and/or communication module of the cochlear implantsystem.
 11. The pairing system of claim 10, wherein for each of the oneor more external devices: once communication between the component andthe cochlear implant system is enabled subsequent communication betweenthe external device and the cochlear implant system can be establishedwithout enabling communication via the external pairing device.
 12. Thepairing system of claim 8, wherein the one or more external devicescomprises a charger, a remote, a fob, a remote microphone, or a deviceconfigurable to stream audio to the cochlear implant system.
 13. Thepairing system of claim 8, wherein: the programming device comprises auser interface; and providing information to each of the one or moreexternal devices to enable communication between each external deviceand the cochlear implant system comprises receiving an input via theuser interface corresponding to the cochlear implant system.
 14. Thepairing system of claim 1, wherein each of the plurality of near fieldcommunication devices of the external pairing device is located beneaththe second surface.
 15. A method of establishing wireless communicationbetween a plurality of external devices and a cochlear implant systemvia a first wireless communication protocol, comprising: positioning anexternal housing carrying the plurality of external devices in acorresponding plurality of compartments adjacent to an external pairingdevice such that each of the plurality of external devices is positionedproximate a corresponding near field communication device of theexternal pairing device, wherein: the external housing includes a firstsurface and a plurality of compartments arranged in a firstconfiguration; each of the plurality of compartments has a uniqueposition within the external housing relative to the first surface;wherein each of the plurality of external devices is positioned within acorresponding one of the plurality of external devices; each of theplurality of external devices comprises a near field communicationdevice and a wireless communication device; the external pairing devicecomprises a second surface and a plurality of near field communicationdevices arranged in a configuration corresponding to the firstconfiguration such that the first surface of the external housing can bealigned with the second surface of the external pairing device in such away that each of the plurality of near field communication devices ofthe external pairing device aligns with a corresponding one of theplurality of compartments of the external housing; such that thepositioning the external housing adjacent to the external pairing devicesuch that each of the plurality of external devices is positionedproximate a corresponding near field communication device of theexternal pairing device establishes near field communication betweeneach external device and the external pairing device; establishingcommunication between a programming device and each of the plurality ofexternal devices via the external pairing device; and for each of theplurality of external devices: communicating information to the externaldevice via its near field communication device and the correspondingnear field communication device of the external pairing device; andenabling communication via the first wireless communication protocolbetween the wireless communication device of the external device and acochlear implant system.
 16. The method of claim 15, wherein theexternal pairing device comprises a mat and the external housingcomprises a box.
 17. The method of claim 15, wherein the second surfaceof the external pairing device comprises indicia representing a desiredlocation and a desired orientation of the external housing, such thatwhen the second surface of the external pairing device receives thefirst surface of the external housing at the desired location and in thedesired orientation, near field communication is established betweeneach of the plurality of external devices and a corresponding near fieldcommunication device of the external pairing device.
 18. The method ofclaim 15, further comprising charging each of the each of the pluralityof external devices when the second surface of the external pairingdevice is placed proximate the first surface of the external housingsuch that each of the plurality of external devices is positionedproximate a corresponding near field communication device of theexternal pairing device.
 19. The method of claim 15, wherein for each ofthe plurality of external devices: once communication between theexternal device and the cochlear implant system via the first wirelesscommunication protocol is enabled for a first time, subsequentconnection between the component and the cochlear implant system can beestablished without establishing near field communication between theexternal device and the external pairing device.
 20. The method of claim15, wherein the enabling communication between each of the plurality ofexternal devices and the cochlear implant system via the first wirelesscommunication protocol further comprises receiving, at each externaldevice, information corresponding to the cochlear implant system, theinformation enabling communication between the external device and thecochlear implant system.
 21. The method of claim 20, wherein thereceived information comprises a media access controller (MAC) addressfor the cochlear implant system.
 22. The method of claim 20, wherein thereceived information comprises a unique device identifier and one ormore encryption keys.